[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma":802},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,210,0,25,[9,49,74,98,110,133,152,172,196,218,247,425,457,481,529,553,575,595,620,631,652,680,698,739,770],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053437",false,"NCT07524530","Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers","Phase II Haploidentical Hematopoietic Stem Cell Transplantation for Participants With Germline RUNX1 Associated Hematologic Malignancies","* INCLUSION CRITERIA:\n* Affected participants (Recipients)\n\n  * History of deleterious or suspected deleterious (defined as P\u002FLP or VUS with RUNX1 phenotype) germline RUNX1 mutation as defined by ClinVar (nih.gov)\n  * Histological confirmation of a myeloid malignancy - acute or chronic leukemia (\\\u003C5% marrow blasts preferred) or myelodysplastic syndrome\u002Fmyeloproliferative neoplasms (MDS\u002FMPN) (\\\u003C10% marrow blasts preferred). Participants may be treated on this study to achieve preferred blast cutoffs. Participants with poorly responsive or relapsed disease remain eligible and may proceed as the graft-versus-leukemia (GVL) effect may produce cures.\n\nSubjects requiring standard therapies to prepare for HCT should ideally be referred to this study in remission, if possible. However, sometimes disease status changes during evaluation for HCT and it is necessary to establish disease control through the administration of standard therapies during evaluation for HCT. If ongoing therapy for the underlying disease outside of the NIH is not in the best interest of the subject according to the clinical judgment of the NIH PI, then the subject may receive standard treatment for his\u002Fher underlying hematologic malignancy as a bridge to HCT on this protocol, prior to starting the research phase of the study. If it becomes apparent that the subject will not be able to proceed to HCT, then he\u002Fshe must come off study. Subjects receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol.\n\n* Availability of a haploidentical donor (HLA-match only).\n* Age \\>= 4 and \\\u003C= 70 years\n* Karnofsky (\\>=16 years) or Lansky (\\\u003C16 years) \\>=60%\n* For human immunodeficiency virus (HIV)-infected participants, participant must be on effective anti-retroviral therapy, without uncontrolled opportunistic infection and have approval via Transplant Infectious Disease consultation. Consider donor with CCR5(delta)32 homozygosity for these participants.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load (VL) must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV VL.\n* Contraception as follows:\n\n  ---Women of child-bearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to and 12 months post conditioning and\u002For post-transplant.\n* Men that can father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 12 months posttransplant or 4 months after conditioning if transplant is not done. We also will recommend men that can father children with partners that can bear children ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men that can father children must not freeze or donate sperm within the same period.\n* Breastfeeding participants must be willing to discontinue breastfeeding during the study and for 12 months post-transplant or 1 week after conditioning if transplant is not done.\n* Willingness to remain in the NIH hospital or, if discharged, stay close to the NIH (30 minutes drive), for a minimum of 100 days after transplant or longer if there are complications. The participants must commit to having an adult caregiver with them during the first 100 days after the transplant\n* Participants or parent\u002Fguardian\u002Flegally authorized representative must be able to understand and willing to sign a written informed consent document.\n* Additional criteria for recipients suitable for MAC\n\n  * Age \\\u003C= 65 years\n  * HCT-CI \\\u003C4\n  * Pulmonary function tests (PFTs): Forced expiratory volume in the first second (FEV1) and adjusted diffusion capacity of carbon monoxide (DLCO) \\>=66%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest.\n  * Left ventricular ejection fraction (LVEF) \\>=50% by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan (101)\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C1.5 x institutional upper limit of normal (iULN) (unless Gilbert disease, hemolysis)\n    * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=2.5 x iULN (unless therapy related and will improve in discussion with the National Institute of Diabetes and Digestive and Kidney Diseases \\[NIDDK\\])\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n* Additional criteria for recipients suitable for RIC\n\n  * Age \\\u003C=70 years\n  * PFTs: FEV1 and DLCO \\>=50%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest\n  * LVEF \\>=40% by ECHO or MUGA obtained within 2 months of HSCT (Children s Oncology Group \\[COG\\] criteria).\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C2.5 x iULN (unless Gilbert disease, hemolysis)\n    * AST\u002FALT \\\u003C3.5 x iULN (unless therapy related and will improve in discussion with NIDDK)\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=50 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the CKD-EPI equation)\n* Unaffected participants\n\n  * Haploidentical donors\n\n    ----Age \\>=4 years\n  * Participants or parent\u002Fguardian must be able to understand and willing to sign a written informed consent document.\n  * Unaffected family members\n\n    * Age \\>=18 years\n    * If the participant is a blood relative of the recipient, participant must be negative for RUNX1 mutations by molecular testing\n    * Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-All participants\n\n* Recipients who are receiving any investigational agent except virus specific T cells (VST)\n* Active non-hematologic malignancies\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in study.\n* Participants with the following cardiac conditions: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (except atrial fibrillation if cleared by cardiology consultation)\n* Participants without access to medical care at home.\n* Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening\n* Uncontrolled intercurrent illness evaluated by history, physical exam, and laboratory studies or situations that would limit compliance with study requirements, interpretation of results or that could increase risk to the participant","ALL","4 Years","70 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nSome blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate.\n\nObjective:\n\nThe primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical\u002Fexpected disease free survival.\n\nEligibility:\n\nPeople aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers.\n\nDesign:\n\nParticipants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken.\n\nA flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge.\n\nParticipants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive radiation treatment. Other tests will include imaging scans. The stem cell transplant will be given through the central line.\n\nAfter discharge from the clinic, participants will have follow-up visits at least once per week for approximately 100 days. Then they will have follow-up clinic visits for 3 years.\n\nDonors, relatives, and healthy volunteers may provide samples of blood, stool, and saliva. Adults may also opt to provide samples of skin and bone marrow.",[27,28,29,30],"Core Binding Factor Alpha Subunits","Hematologic Neoplasms","Leukemia","Lymphoma",[32,33,34,35],"RUNX1","Haploidentical Hematopoietic Stem Cell Transplant","Germline RUNX1","germline RUNX1-aassociated myeloid malignancy","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2036-06-01",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100053225","NCT07302347","A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21\u002FKEYNOTE-G21)","A Phase I\u002FII Study of Pembrolizumab (MK-3475) in Japanese Pediatric Participants With Specific Solid Tumors or Lymphomas, or in Japanese Adult Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-G21)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\nArm 1:\n\n* For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL)\n\n  * Has a confirmed diagnosis of relapsed or refractory cHL or PMBCL after the most recent therapy\n  * Has radiographically measurable disease per Lugano classification\n* For participants with completely resected melanoma:\n\n  * Has surgically completely resected and histologically\u002Fpathologically confirmed diagnosis of Stage IIB, IIC, III or IV cutaneous melanoma\n  * Has not received any prior systemic therapy for their melanoma beyond surgical resection\n  * All suspicious lesions amenable to biopsy are confirmed negative for malignancy\n* For participants with locally advanced or metastatic melanoma:\n\n  * Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma (including acral) not amenable to local therapy\n  * Has radiographically measurable lesion(s) as defined by RECIST 1.1\n* For participants with microsatellite instability-high (MSI-H)\u002Fmismatch repair deficiency (dMMR) solid tumors:\n\n  * Has histologically\u002Fcytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician\n  * Has a documented positive local MSI-H or dMMR test result\n  * Has radiographically measurable disease based on RECIST 1.1\n* For participants with tumor mutational burden-high (TMB-H) solid tumors:\n\n  * Has histologically\u002Fcytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician\n  * Has radiographically measurable disease based on RECIST 1.1\n* For participants with MCC:\n\n  * Has histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and\u002For radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV)\n  * Has radiographically measurable disease based on RECIST 1.1\n\nArm 2:\n\n* For participants with MCC:\n\n  * Has been untreated for advanced or metastatic disease\n\nArm 1 \\& Arm 2:\n\n* Life expectancy of \\>3 months (Arm 1) or \\>6 months (Arm 2)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has known additional malignancy that is progressing or has required active treatment\n* Has known active (central nervous system) CNS metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in past 2 years\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* Has known history of human immunodeficiency virus (HIV) infection\n* Has known history of Hepatitis B infection or known active Hepatitis C virus\n* Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n* Has not adequately recovered from major surgery or has ongoing surgical complications","6 Months",{"count":57,"type":21},20,[59,24],"PHASE1","Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn:\n\n* About the safety of pembrolizumab (the study medicine) and if people tolerate it\n* What happens to different doses of pembrolizumab in a person's body over time\n* How the cancer responds (gets smaller or goes away) to treatment",[62,63,30],"Malignant Neoplasm","Carcinoma, Merkel Cell","RECRUITING",{"date":39,"type":40},{"date":67,"type":40},"2026-06-23",{"date":69,"type":21},"2029-12-31",{"name":71,"class":72},"Merck Sharp & Dohme LLC","INDUSTRY",7,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100054233","NCT07698080","Dexamethasone, Intravenous Injection of Human Immunoglobulin, and Increased Infusion of Mononuclear Cells to Reduce Donor Specific Antibodies in Haploid Hematopoietic Stem Cell Transplantation: a Prospective, Multicenter Study","Inclusion Criteria:\n\n1. Diagnosis of benign or malignant hematological diseases (including leukemia, lymphoma, thalassemia, aplastic anemia, myelodysplastic syndromes, etc.) confirmed by NCCN guidelines, and determined by the investigator to require allogeneic hematopoietic stem cell transplantation.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.\n3. Donor-specific antibody (DSA) mean fluorescence intensity (MFI) \\> 500.\n4. Age between 18 and 65 years (age limits are also captured separately in the eligibility module).\n5. Body weight between 40 kg and 100 kg.\n6. No other suitable donor available (i.e., no DSA-negative related donor or unrelated donor).\n\nExclusion Criteria:\n\n1. Patients unsuitable for transplantation or without willingness to undergo transplantation, or diagnosed with non-hematological diseases.\n2. Estimated life expectancy \\\u003C 1 month.\n3. Known allergy to any drug or intervention used in the study regimen.\n4. Pregnancy, lactation, active severe infection, or severe major organ dysfunction.\n5. Severe psychiatric or neurological disorders that may affect the ability to provide informed consent and\u002For to report adverse events or comply with observation.\n6. Refusal or inability to sign the informed consent form.","18 Years","65 Years",{"count":82,"type":21},60,[24],"This study tests whether a combination of three treatments - dexamethasone (a steroid), intravenous immunoglobulin (IVIG, a protein that helps the immune system), and an extra dose of donor mononuclear cells - can safely lower harmful antibodies called donor-specific antibodies (DSA) in patients who need a stem cell transplant from a half-matched (haploidentical) family donor.\n\nIn these transplants, DSA are antibodies made by the patient's own body that attack the donor's stem cells. If DSA levels are high, the transplant is more likely to fail - the donor cells may not \"take\" (engraft). Currently, there is no single, simple, and reliable way to reduce DSA, and many existing methods have drawbacks.\n\nBased on our earlier experience in 11 patients, this three-part approach seemed to work well. All patients successfully engrafted, and DSA levels dropped quickly. Now we want to confirm these results in a larger, prospective, multicenter study.\n\nWe plan to enroll 60 patients aged 18-65 with blood cancers or other blood disorders who need a haploidentical transplant, have DSA levels above 500 MFI (a measure of antibody strength), and have no other suitable donor available. Participants will receive:\n\n* Dexamethasone (25 mg\u002Fm²) for 4 days before transplant,\n* IVIG (1 g\u002Fkg) one day before transplant,\n* Extra mononuclear cells on transplant day - the extra amount depends on how high their DSA level is (low, medium, or high).\n\nThe main goal is to see how many patients have primary graft failure (when the donor cells never engraft). We will also measure how long it takes for blood counts to recover, rates of graft-versus-host disease, survival, and side effects. All participants will be followed for 1 year.\n\nThis study will help us find out whether this combination is a safe, simple, and effective way to improve transplant success for patients with DSA who have no other donor options.",[29,30,86,87,88],"Thalassemia","Aplastic Anemia","Myelodysplastic Syndromes","2026-07-07",{"date":39,"type":40},{"date":92,"type":21},"2026-07-03",{"date":94,"type":21},"2028-07-03",{"name":96,"class":97},"Hematology department of the 920th hospital","OTHER",{"id":99,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":25,"conditions":102,"keywords":103,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":109,"locationsCount":48},"100633272",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34,35],"2026-07-01",{"date":106,"type":40},"2026-07-02",{"date":89,"type":21},{"date":44,"type":21},{"name":46,"class":47},{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100594115","NCT07015242","A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma","The CAROLYN Trial: Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients","Inclusion Criteria\n\n* Participant must be 18 years or older at the time of signing the informed consent form (ICF).\n* Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology.\n* Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3.\n* Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen.\n* Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must be limited to HD-MTX based standard of care regimens with a minimum of 4 and maximum of 6 doses of MTX. Corticosteroids used as part of standard-of-care management for PCNSL symptom control are permitted prior to ICF signature but must be discontinued at the time of ICF signature. For medical conditions other than PCNSL, non-therapeutic corticosteroids use may be permitted on study.\n* Prior to ICF enrollment, participant's disease must be sensitive to prior high-dose methotrexate-based (HD-MTX) regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.\n\nExclusion Criteria\n\n* Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.\n* Primary intraocular lymphoma (PIOL)\u002F Primary vitreoretinal lymphoma (PVRL), isolated cerebrospinal fluid (CSF) disease, or a relapsed or refractory PCNSL.\n* Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he\u002Fshe was to participate in the study based on investigator's judgement.\n* History of another primary malignancy that has not been in remission for ≥2 years.\n* Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.\n* History of or active human immunodeficiency virus (HIV).\n* Active hepatitis B or active hepatitis C.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* History of prior allogeneic transplant, or solid organ transplant requiring immunosuppressive therapy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":117,"type":21},65,[24],"The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi\u002Fliso-cel\u002FBMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).",[30],[122,123,124],"primary CNS lymphoma","newly diagnosed","JCAR017",{"date":106,"type":40},{"date":127,"type":40},"2025-11-06",{"date":129,"type":21},"2028-12-10",{"name":131,"class":72},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",40,{"id":134,"slug":4,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100564047","NCT06624085","A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed DLBCL, not otherwise specified (NOS)\n* Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \\\u003C 6 months after completion of the last line of therapy) disease\n* At least one prior line of systemic therapy\n* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)\n* At least one bi-dimensionally measurable (\\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\\> 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Prior enrollment in Study GO41944 (STARGLO; NCT04408638)\n* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation\n* History of transformation of indolent disease to DLBCL\n* High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines\n* Primary mediastinal B-cell lymphoma\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with gemcitabine or oxaliplatin\n* Peripheral neuropathy or paresthesia assessed to be Grade \\>\u002F= 2 according to NCI CTCAE v5.0 at enrollment\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment\n* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* History of other primary malignancy, with exceptions defined by the protocol\n* Significant or extensive cardiovascular disease, or significant pulmonary disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment\n* Suspected or latent tuberculosis\n* Positive test results for hepatitis B (HBV) or hepatitis C (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy\n* Prior solid organ transplantation\n* Prior allogenic stem cell transplant\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment\n* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease",{"count":140,"type":21},50,[59],"The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL).",[30],{"date":106,"type":40},{"date":146,"type":40},"2025-04-28",{"date":148,"type":21},"2030-03-31",{"name":150,"class":72},"Hoffmann-La Roche",18,{"id":153,"slug":4,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100522616","NCT06084936","A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","GLOBRYTE","Inclusion Criteria:\n\n* Life expectancy at least 12 weeks\n* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry\n* Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease\n* At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option\n* Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment\n* At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Negative HIV test at screening\n* Adequate hematological function\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer\n* Leukemic, non-nodal MCL\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with CAR-T cell therapy\n* Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Significant or extensive cardiovascular disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Suspected or latent tuberculosis\n* Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection (EBV)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy (PML)\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation or allogenic stem cell transplant\n* Eligibility for stem cell transplantation (SCT)\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment\n* Corticosteroid therapy within 2 weeks prior to first dose of study treatment\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease",{"count":160,"type":21},182,[162],"PHASE3","The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R\u002FR) mantle cell lymphoma (MCL).",[30],{"date":106,"type":40},{"date":167,"type":40},"2023-10-22",{"date":169,"type":21},"2028-03-31",{"name":150,"class":72},77,{"id":173,"slug":4,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":48},"100452353","NCT05170399","Vaccine Responses in Patients With B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM\n* Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:\n\n  1. Patients with CLL AND one of the following:\n\n     i. Arm 1: Must be treatment naive (no prior cancer directed therapy)\n\n     ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment\n\n     iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine\n\n     iv. Arm 4: Must be receiving treatment with a BTKi for \\>= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.\n\n     v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor\n\n     Or\n  2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:\n\n     i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)\n\n     ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)\n* If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response\n* Age \\>= 18 years\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1. Female patients who are currently pregnant\n2. History of severe allergic reaction to vaccines\n3. Concomitant inherited immunodeficiency\n4. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk.\n5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination\n6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination\n7. Receive anti-CD20 and\u002For anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination\n8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination\n9. History of allogeneic stem cell transplantation","90 Years",{"count":179,"type":21},350,[181],"PHASE4","Background:\n\nPeople with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.\n\nObjective:\n\nTo learn how well vaccines work in people who have certain types of blood cancers.\n\nEligibility:\n\nAdults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.\n\nDesign:\n\nParticipants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.\n\nParticipants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.\n\nParticipants will have pregnancy tests, if needed.\n\nParticipants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.\n\nParticipants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.\n\nParticipation will last for up to 5 years after each vaccine series is received.",[30],[185,186,187,30,188],"CLL","SLL","Booster","Vaccines",{"date":106,"type":40},{"date":191,"type":40},"2022-09-14",{"date":193,"type":21},"2026-08-16",{"name":195,"class":47},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":197,"slug":4,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":210,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":48},"100305619","NCT03258567","Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas","Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas","* INCLUSION CRITERIA:\n* Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.\n\n  * EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.\n\n    1. Lymphomatoid granulomatosis (LYG), grades I-II\n    2. Chronic active EBV disease (CAEBV) of B-cells or T-cells\n    3. EBV-positive post-transplantation lymphoproliferative disorder (PTLD)\n\n       NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible.\n  * EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same.\n\n    1. Lymphomatoid granulomatosis (LYG), grade III\n    2. EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\n    3. EBV-positive DLBCL\n* Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)\n* Subjects must be at least 100 days from prior stem cell transplant (autologous or allogeneic) or Donor Lymphocyte Infusion (DLI)\n\n  * Age \\>=12 years\n  * Patients \\>= 12 and \\\u003C 18 years of age should weigh at least 40 kilograms (kg); there is no weight requirement for adult subjects.\n  * NOTE: If a pediatric patient is identified for possible enrollment who weighs less than 40 kg, the safety of the nivolumab dosing strategy used in this study must be discussed with the PI and manufacturer to confirm safety, and this discussion\u002Fapproval for enrollment documented in the medical record prior to declaring the pediatric patient eligible.\n* Adequate performance status as follows:\n\n  * Patients \\>= 16 years must have ECOG Performance Status 0-2 (Karnofsky \\>=60%)\n  * Pediatric patients \\\u003C 16 years must have Lansky play-performance of 60-100%\n* Subjects must have measurable or evaluable disease.\n* Subjects must have adequate organ and bone marrow reserve (unless disease-related) as defined below:\n\n  * absolute neutrophil count - \\>= 750\u002FmcL; \\>= 500\u002FmcL if impairment is due to LPD\u002FNHL\n  * platelets - \\>= 50,000\u002FmcL; \\>= 25,000\u002FmcL if impairment is due to LPD\u002FNHL (transfusions not permitted)\n  * Hemoglobin - \\>= 9g\u002FdL (transfusion permitted)\n  * total bilirubin - \\\u003C 3.0g\u002Fdl OR \\\u003C 5.0g\u002Fdl if Gilbert s syndrome or disease infiltration of the liver is present\n  * AST(SGOT)\u002FALT(SGPT) - \\\u003C= 3 X institutional upper limit of normal\n  * serum creatinine OR creatinine clearance - Adults: \\\u003C= 1.5 mg\u002FdL; Minors: serum Cr \\\u003C= age-adjusted normal OR \\>= 40 ml\u002Fmin\u002F1.73m\\^2\n\nAge(Years) 12-15: Maximum Serum Creatinine (mg\u002Fdl): 1.2\n\nAge(Years) \\> 15: Maximum Serum Creatinine (mg\u002Fdl): 1.5\n\n* A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available.\n* The toxicity profile of nivolumab in patients with disease involvement of the central nervous system (CNS) is unknown. For this reason, we will introduce early stopping rules.\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, the following measures apply:\n\n  * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) during screening and within 48 hours prior to the first dose of nivolumab.\n  * WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year or abstinence) prior to study entry and throughout study drug administration. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.\n  * Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal. Post menopause is defined as:\n\n    1. Amenorrhea \\>= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or\n    2. Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or NOTE: FSH level testing is not required for women \\>= 62 years old with amenorrhea of \\>= 1 year\n    3. Women on hormone replacement therapy (HRT)\n* Pregnant women are excluded from this study because nivolumab is an IgG monoclonal antibody with the potential for teratogenic or abortifacient effects.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, nursing should be discontinued if the mother is treated with nivolumab.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and sign the written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.\n* Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.\n* Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.\n* Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \\>=grade II acute GVHD or extensive chronic GVHD.\n* Subjects who have had solid organ transplant.\n* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody.\n* Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.\n* A serious uncontrolled medical condition requiring therapy.\n* Seizures disorder not controlled by anti-seizure medications.\n* Subjects with CNS involvement may be included on the study as long as they have not had any seizure activity in past 4 weeks.\n* Hepatitis B virus surface antigen positive.\n* Active Hepatitis C infection with a positive PCR; subjects who are Hepatitis C antibody positive and PCR negative may be eligible. In these cases, the subjects will be monitored via HCV PCR throughout the study.\n* History of anaphylactic reaction to monoclonal antibody therapy.\n* HIV positive subjects are excluded because the function of their T-cell immune responses is impaired.","12 Years",{"count":132,"type":21},[24],"Background:\n\nThe drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments.\n\nObjectives:\n\nTo see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug.\n\nEligibility:\n\nPeople 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nCAT scan of the chest, abdomen, and pelvis\n\nTumor and bone marrow biopsies (sample taken)\n\nMagnetic resonance imaging scan of the brain\n\nLumbar puncture (also known as spinal tap)\n\nPositron emission tomography\u002Fcomputed tomography scan with a radioactive tracer\n\nEvery 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have:\n\nPhysical exam\n\nBlood and pregnancy tests\n\nReview of side effects and medications\n\nDuring the study, participants will repeat most of the screening tests. They may also have other biopsies.\n\nAfter stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.\n\n...",[207,30,208,209],"Epstein-Barr Virus Infections","Lymphoproliferative Disorder","Disorders, Lymphoproliferative",[211],"Monoclonal Antibody",{"date":106,"type":40},{"date":214,"type":40},"2018-04-26",{"date":216,"type":21},"2031-06-01",{"name":46,"class":47},{"id":219,"slug":4,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":226,"conditions":227,"keywords":236,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":48},"100582251","NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention",{"count":132,"type":21},[225],"NA","This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[228,30,229,230,231,232,233,234,235],"Indolent Lymphomas","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Waldenstrom Macroglobulinemia","Cutaneous T Cell Lymphoma",[237,238],"exercise","dietary intervention","2026-06-29",{"date":104,"type":40},{"date":242,"type":40},"2025-06-03",{"date":244,"type":21},"2026-12-31",{"name":246,"class":97},"UNC Lineberger Comprehensive Cancer Center",{"id":248,"slug":4,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":256,"conditions":257,"keywords":263,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":73},"100143410","NCT01137825","Registry of Older Patients With Cancer","Carolina Senior: UNC Registry for Older Cancer Patients","DISEASE CHARACTERISTICS:\n\n* Patients must have an appointment at the North Carolina Cancer Hospital and agree to complete the Geriatric Assessment NOTE: Not all patients included in the registry will ultimately be diagnosed with cancer. Patients who complete a GA and are not diagnosed with cancer will remain in the database, but will be categorized into a separate group and will not have their medical records accessed.\n\nPATIENT CHARACTERISTICS:\n\n* Able to read and speak English\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified",{"count":254,"type":21},3000,"OBSERVATIONAL","RATIONALE: Gathering information about older patients with cancer may help the study of cancer in the future.\n\nPURPOSE: This research study is gathering information from older patients with cancer into a registry.",[258,259,29,30,208,260,88,261,262],"Chronic Myeloproliferative Disorders","Cognitive\u002FFunctional Effects","Multiple Myeloma and Plasma Cell Neoplasm","Myelodysplastic\u002FMyeloproliferative Neoplasms","Unspecified Adult Solid Tumor, Protocol Specific",[264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417],"cognitive\u002Ffunctional effects","unspecified adult solid tumor, protocol specific","accelerated phase chronic myelogenous leukemia","acute undifferentiated leukemia","adult acute lymphoblastic leukemia in remission","adult acute myeloid leukemia in remission","adult acute myeloid leukemia with 11q23 (MLL) abnormalities","adult acute myeloid leukemia with inv(16)(p13;q22)","adult acute myeloid leukemia with t(15;17)(q22;q12)","adult acute myeloid leukemia with t(16;16)(p13;q22)","adult acute myeloid leukemia with t(8;21)(q22;q22)","atypical chronic myeloid leukemia, BCR-ABL negative","blastic phase chronic myelogenous leukemia","chronic myelomonocytic leukemia","chronic phase chronic myelogenous leukemia","mast cell leukemia","meningeal chronic myelogenous leukemia","progressive hairy cell leukemia, initial treatment","prolymphocytic leukemia","recurrent adult acute lymphoblastic leukemia","recurrent adult acute myeloid leukemia","recurrent adult T-cell leukemia\u002Flymphoma","refractory chronic lymphocytic leukemia","refractory hairy cell leukemia","relapsing chronic myelogenous leukemia","secondary acute myeloid leukemia","stage 0 chronic lymphocytic leukemia","stage I adult T-cell leukemia\u002Flymphoma","stage I chronic lymphocytic leukemia","stage II adult T-cell leukemia\u002Flymphoma","stage II chronic lymphocytic leukemia","stage III adult T-cell leukemia\u002Flymphoma","stage III chronic lymphocytic leukemia","stage IV adult T-cell leukemia\u002Flymphoma","stage IV chronic lymphocytic leukemia","T-cell large granular lymphocyte leukemia","untreated adult acute lymphoblastic leukemia","untreated adult acute myeloid leukemia","untreated hairy cell leukemia","recurrent adult Hodgkin lymphoma","stage I adult Hodgkin lymphoma","stage II adult Hodgkin lymphoma","stage III adult Hodgkin lymphoma","stage IV adult Hodgkin lymphoma","anaplastic large cell lymphoma","angioimmunoblastic T-cell lymphoma","cutaneous B-cell non-Hodgkin lymphoma","recurrent cutaneous T-cell non-Hodgkin lymphoma","stage I cutaneous T-cell non-Hodgkin lymphoma","stage II cutaneous T-cell non-Hodgkin lymphoma","stage III cutaneous T-cell non-Hodgkin lymphoma","stage IV cutaneous T-cell non-Hodgkin lymphoma","recurrent mycosis fungoides\u002FSezary syndrome","stage I mycosis fungoides\u002FSezary syndrome","stage II mycosis fungoides\u002FSezary syndrome","stage III mycosis fungoides\u002FSezary syndrome","stage IV mycosis fungoides\u002FSezary syndrome","adult grade III lymphomatoid granulomatosis","adult nasal type extranodal NK\u002FT-cell lymphoma","Waldenstrom macroglobulinemia","extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue","nodal marginal zone B-cell lymphoma","splenic marginal zone lymphoma","contiguous stage II adult Burkitt lymphoma","contiguous stage II adult diffuse large cell lymphoma","contiguous stage II adult diffuse mixed cell lymphoma","contiguous stage II adult diffuse small cleaved cell lymphoma","contiguous stage II adult immunoblastic large cell lymphoma","contiguous stage II adult lymphoblastic lymphoma","contiguous stage II grade 1 follicular lymphoma","contiguous stage II grade 2 follicular lymphoma","contiguous stage II grade 3 follicular lymphoma","contiguous stage II mantle cell lymphoma","contiguous stage II marginal zone lymphoma","contiguous stage II small lymphocytic lymphoma","stage I adult Burkitt lymphoma","stage I adult diffuse large cell lymphoma","stage I adult diffuse mixed cell lymphoma","stage I adult diffuse small cleaved cell lymphoma","stage I adult immunoblastic large cell lymphoma","stage I adult lymphoblastic lymphoma","stage I grade 1 follicular lymphoma","stage I grade 2 follicular lymphoma","stage I grade 3 follicular lymphoma","stage I mantle cell lymphoma","stage I marginal zone lymphoma","stage I small lymphocytic lymphoma","noncontiguous stage II adult Burkitt lymphoma","noncontiguous stage II adult diffuse large cell lymphoma","noncontiguous stage II adult diffuse mixed cell lymphoma","noncontiguous stage II adult diffuse small cleaved cell lymphoma","noncontiguous stage II adult immunoblastic large cell lymphoma","noncontiguous stage II adult lymphoblastic lymphoma","noncontiguous stage II grade 1 follicular lymphoma","noncontiguous stage II grade 2 follicular lymphoma","noncontiguous stage II grade 3 follicular lymphoma","noncontiguous stage II mantle cell lymphoma","noncontiguous stage II marginal zone lymphoma","noncontiguous stage II small lymphocytic lymphoma","stage III adult Burkitt lymphoma","stage III adult diffuse large cell lymphoma","stage III adult diffuse mixed cell lymphoma","stage III adult diffuse small cleaved cell lymphoma","stage III adult immunoblastic large cell lymphoma","stage III adult lymphoblastic lymphoma","stage III grade 1 follicular lymphoma","stage III grade 2 follicular lymphoma","stage III grade 3 follicular lymphoma","stage III mantle cell lymphoma","stage III marginal zone lymphoma","stage III small lymphocytic lymphoma","stage IV adult Burkitt lymphoma","stage IV adult diffuse large cell lymphoma","stage IV adult diffuse mixed cell lymphoma","stage IV adult diffuse small cleaved cell lymphoma","stage IV adult immunoblastic large cell lymphoma","stage IV adult lymphoblastic lymphoma","stage IV grade 1 follicular lymphoma","stage IV grade 2 follicular lymphoma","stage IV grade 3 follicular lymphoma","stage IV mantle cell lymphoma","stage IV marginal zone lymphoma","stage IV small lymphocytic lymphoma","recurrent adult Burkitt lymphoma","recurrent adult diffuse large cell lymphoma","recurrent adult diffuse mixed cell lymphoma","recurrent adult diffuse small cleaved cell lymphoma","recurrent adult grade III lymphomatoid granulomatosis","recurrent adult immunoblastic large cell lymphoma","recurrent adult lymphoblastic lymphoma","recurrent grade 1 follicular lymphoma","recurrent grade 2 follicular lymphoma","recurrent grade 3 follicular lymphoma","recurrent mantle cell lymphoma","recurrent marginal zone lymphoma","recurrent small lymphocytic lymphoma","intraocular lymphoma","post-transplant lymphoproliferative disorder","chronic eosinophilic leukemia","chronic neutrophilic leukemia","primary myelofibrosis","essential thrombocythemia","polycythemia vera","extramedullary plasmacytoma","isolated plasmacytoma of bone","stage I multiple myeloma","stage II multiple myeloma","stage III multiple myeloma","primary systemic amyloidosis","refractory multiple myeloma","de novo myelodysplastic syndromes","previously treated myelodysplastic syndromes","secondary myelodysplastic syndromes","myelodysplastic\u002Fmyeloproliferative neoplasm, unclassifiable","2026-06-24",{"date":239,"type":40},{"date":421,"type":4},"2009-09",{"date":423,"type":21},"2030-12",{"name":246,"class":97},{"id":426,"slug":4,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":443,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":456},"100526622","NCT06137144","AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.","A Modular Phase I\u002FII, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies","PRIMAVERA","Inclusion Criteria:\n\nCore Inclusion criteria:\n\n1. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments\n2. Adequate organ and bone marrow function.\n\nModule 1 Cohort 1:\n\n1. Age:\n\n   1. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.\n   2. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r\u002Fr active disease requiring treatment.\n4. Participants must provide FFPE baseline tumour tissue.\n5. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesion ( \\>1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n\nModule 1 Cohort 2:\n\n1. Participants must be at least 50 years of age or older at study entry.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. Ann Arbor stages III or IV.\n4. Participant must have previously received at least 4 cycles of SoC combination therapy with A-AVD, N-AVD, AVD, or ABVD (based on regional SOC, per investigator) as finite first-line induction therapy, and achieved at least a PR post-induction therapy.\n5. Participants must provide FFPE baseline tumour tissue.\n\nModule 1 Cohort 3:\n\n1. Participants must be aged ≥ 18 years at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of PTCL NOS, systemic ALCL, or AITL based on WHO criteria.\n3. Participants must have received at least 1 prior line of therapy for the treatment of PTCL and have exhausted all available therapies with demonstrated clinical benefit. Participants with ALCL must have received prior BV treatment.\n4. Participants must provide FFPE baseline tumour tissue\n\n   a. Ability to provide an on-treatment biopsy (if the tumour is suitable for biopsy).\n5. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesions (\\> 1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n\nModule 2 Cohort 1:\n\n1. Participants must be aged ≥ 18 years at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of cHL based on WHO criteria\n3. At least 1 radiographically measurable, and\u002For FDG-avid lymphoma lesions (\\> 1.5 cm for nodal lesion and \\>1 cm for extranodal lesion).\n4. Participant must have received at least 1 prior line of therapy for the treatment of cHL and have documented r\u002Fr active disease requiring treatment.\n5. Participants must provide FFPE baseline tumour tissue.\n\nExclusion Criteria:\n\nCore Exclusion criteria:\n\n1. Any significant laboratory finding or any severe and uncontrolled medical condition.\n2. Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.\n3. Serologic active HBV or HCV infection.\n4. Known to have tested positive for HIV.\n5. Active gastrointestinal disease or other condition that will interfere with oral therapy.\n6. Any of the following ECG cardiac criteria: Mean resting QTcF \\> 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and\u002For any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n7. Undergone any of the following procedures within 6 months prior to first dose:\n\n   1. Coronary artery bypass graft,\n   2. Percutaneous coronary intervention or heart valve replacement or repairment,\n   3. Vascular stent implantation (venous stent is eligible),\n   4. Acute coronary syndrome \u002F myocardial infarction,\n   5. Unstable or poorly controlled angina pectoris,\n   6. Ventricular arrhythmias requiring continuous therapy,\n   7. Uncontrolled atrial fibrillation,\n   8. Haemorrhagic or thrombotic stroke (including transient ischaemic attacks) or any other CNS bleeding.\n   9. Acute venous or atrial thromboembolic event (unless considered stable or adequately treated with at least 3months of therapeutic anticoagulation).\n8. Severe valvular heart disease.\n9. Congestive heart failure Grade II to Grade IV.\n10. Prior or current cardiomyopathy.\n11. Uncontrolled hypertension.\n12. History of significant haemoptysis or haemorrhage within4 weeks of the first dose of study treatment.\n13. Unresolved toxicities of Grade \\> 1 from prior anti cancer therapy (excluding peripheral neuropathy, vitiligo, alopecia and endocrine disorders that are controlled with replacement hormone therapy, and asymptomatic laboratory abnormalities), unless immune-mediated.\n14. History of another primary malignancy.\n15. Received the following anticancer therapies: anti-lymphoma therapy (within 21 days), radiation therapy(within 28 days), allo-HSCT (within 180 days), auto-HSCT\u002Fcellular therapy (within 60 days), or MAT2A or PRMT5 inhibitor\n16. Requires ongoing immunosuppressive therapy, including systemic corticosteroids.\n\nModule 2 Cohort 1:\n\n1. History of confirmed ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment or any evidence of clinically active ILD or pneumonitis.\n2. ≥Grade 3 immune-mediated AE while receiving prior checkpoint inhibitor immunotherapy, or any unresolved ≥Grade 2 immune-mediated AE.\n3. History of immune-mediated myocarditis or pericarditis.\n4. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n5. Active or prior documented pathologically confirmed autoimmune or inflammatory disorders\n6. Refractory to prior checkpoint inhibitor therapy (within 12 weeks of last dose)\n7. Eligible for allogeneic or autologous stem cell transplant.\n8. Received an allogeneic HSCT within 5 years of the first dose of study treatment; must not have active Graft-versus-host disease.\n9. Participants with a known hypersensitivity to pembrolizumab or any of the excipients of the product.",{"count":433,"type":21},161,[59,24],"This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.",[30,437,438,439,440,441,442],"Non-Hodgkin Lymphoma","Hodgkin Lymphoma","Peripheral T-cell Lymphoma (PTCL)","PTCL-NOS","ALCL","AITL",[444,445,446,447,448],"Haematologic Malignancies","Hodgkin lymphoma","Peripheral T-cell lymphoma (PTCL)","Methylthioadenosine Phosphorylase (MTAP) deficient","Protein Arginine Methyltransferase 5 (PRMT5)",{"date":418,"type":40},{"date":451,"type":40},"2024-01-23",{"date":453,"type":21},"2029-05-03",{"name":455,"class":72},"AstraZeneca",37,{"id":458,"slug":4,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":16,"minAge":463,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":470,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":480},"100406285","NCT04570423","A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","Inclusion Criteria:\n\n1. Participant must have a pathologic\u002Fhistologic confirmed newly diagnosed\u002Frelapsed\u002Frecurrent solid tumor or lymphoma without bone marrow involvement.\n2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Participant has adequate hematological, renal, and hepatic function.\n4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \\>50%.\n5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.\n6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \\\u003C16 years of age.\n\nExclusion Criteria:\n\n1. Participant has an uncontrollable infection, has an underlying medical condition, and\u002For another serious illness that would impair the ability of the participant to receive protocol-specified treatment.\n2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)\n3. Participant requires concurrent radiation therapy specifically in Cycle 1.\n4. Participant has had prior bone marrow or hematopoietic stem cell transplant and\u002For has concurrent bone marrow involvement in their malignancy, including leukemia.\n5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.\n6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.\n7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.\n8. Participant with active CNS disease.\n9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.","1 Month","17 Years",{"count":132,"type":21},[24],"The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.",[469,30],"Solid Tumors",[471,469,472],"Lymphomas","Chemotherapy",{"date":418,"type":40},{"date":475,"type":40},"2021-05-20",{"date":477,"type":21},"2027-10",{"name":479,"class":72},"Spectrum Pharmaceuticals, Inc",5,{"id":482,"slug":4,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":516,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":48},"100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":489,"type":21},300,[24],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[493,494,495,30,496,497,498,499,500,501,502,229,230,503,231,233,504,505,506,507,508,509,510,511,512,513,514,515],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[517,16,518,519,185,520,186],"AML","MDS","NHL","CML",{"date":522,"type":40},"2026-06-25",{"date":524,"type":40},"2018-03-30",{"date":526,"type":21},"2028-06-10",{"name":528,"class":97},"Masonic Cancer Center, University of Minnesota",{"id":530,"slug":4,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":535,"sex":16,"minAge":536,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100457545","NCT05237986","Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed\u002FRefractory Hematologic Malignancies Who Receive CAR T-cell Therapy","Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed\u002FRefractory Hematologic Malignancies Who Receive CAR T-cell Therapy","* INCLUSION CRITERIA:\n* Participants with disease\n\n  * Participants are diagnosed with relapsed\u002Frefractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites\n  * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.\n  * Age \\>= 5 and \\\u003C=35 years old\n  * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study\n  * Participants (\\\u003C18 years, or \\>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations\n  * Participant must be able to speak and understand English or Spanish\n  * Participants must have access to a computer or tablet with a camera and an internet connection\n  * Participant or parent\u002Fguardian must be able to understand and willing to sign a written consent document\n* Caregivers (informants)\n\n  * Participants must be able to speak and read in English or Spanish\n  * Participants who are caregivers for participants with disease addressed above\n  * Age \\>= 18 years old\n  * Participants must have access to a computer or tablet\n  * Participants (of children \\\u003C18 years, or \\>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations\n  * Participant is able to understand and willing to sign a written consent document\n\nEXCLUSION CRITERIA:\n\n-Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)",true,"5 Years",{"count":82,"type":21},"Background:\n\nCAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills.\n\nObjective:\n\nTo learn if CAR T-cell therapy can affect how children and adults think, process, and remember things.\n\nEligibility:\n\nPeople aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish.\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nInformation from participants medical records will be collected.\n\nParticipants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper\u002Fpencil. They will take less than 1 hour to complete.\n\nParticipants and a parent\u002Fadult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms.\n\nIf participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things.\n\nParticipants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete.\n\nSome tests and questions will be repeated at different time points in the study.\n\nParticipation will last for up to 3 years.",[30,29],[541,542,29,30,543],"Cogstate","Memory","Natural History","2026-06-17",{"date":546,"type":40},"2026-06-18",{"date":548,"type":40},"2025-06-23",{"date":550,"type":21},"2028-12-01",{"name":46,"class":47},3,{"id":554,"slug":4,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":48},"100302934","NCT03223610","Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","Phase 1b\u002F2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows:\n\nPhase1b\n\n* Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n\n  -Indolent B-cell lymphoma:\n* CLL\u002FSLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL\u002FSLL compared to other non-Hodgkin lymphomas.\n\n  * NOTE: Patients with known active CNS lymphoma are not eligible.\n\nPhase 2\n\n* Relapsed and\u002For refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n* Relapsed and\u002For refractory Follicular lymphoma (FL)\n* Relapsed and\u002For refractory and untreated Mantle cell lymphoma (MCL)\n* Relapsed and\u002For refractory disease on at least 1 prior treatment regimen, as follows:\n\n  * Aggressive B-cell lymphoma:relapsed after and\u002For refractory to at least 1 prior anthracycline-containing regimen\n  * Indolent B-cell lymphoma: relapsed after and\u002For refractory to at least 1 prior anti-CD20 antibody-containing regimen.\n* NOTE: Patients with untreated and relapsed and\u002For refractory MCL will be included in the phase 2 MCL expansion.\n* Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and\u002For imaging (measurable lymph nodes or masses on CT or MRI and\u002For evaluable FDG-avid lesions on PET).\n* NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.\n* Age greater than or equal to 18 years\n* NOTE: Because no dosing or adverse event data are currently available on the use of venetoclax in combination with ibrutinib, obinutuzumab, prednisone and Revlimid(R) in patients \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status less than or equal to 2\n* Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma:\n\n  * absolute neutrophil count\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 1,000\u002FmcL\n  * hemoglobin\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 8 g\u002FdL\n  * platelets greater than or equal to 75,000\u002FmcL\n  * INR: less than or equal to 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation\n  * PTT\u002FaPTT: less than or equal to 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant\n  * Total Bilirubin: less than or equal to 1.5 X institutional ULN (or less than or equal to 3 X institutional ULN for patients with documented Gilberts syndrome)\n  * AST(SGOT)\u002FALT(SGPT): less than or equal to 2.5 X institutional ULN\n  * Serum Creatinine: less than or equal to 2.0mg\u002FdL OR\n  * Creatinine Clearance: greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 2 mg\u002FdL\n\nCr Cl will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \\[IBM\\] instead of mass):\n\n(140 - Age) x IBM (kg) x \\[0.85 if female\\]\u002F 72 x serum creatinine (mg\u002FdL)\n\n\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n* Immune-modulating drugs (IMiDs) including Revlimid(R) are known to be teratogenic and potential embryo-fetal harm can be seen with use of venetoclax and ibrutinib. The effects of obinutuzumab on the developing human fetus is unknown. For these reasons, women of child-bearing potential and men must agree to use adequate contraception as described below.\n* For women of childbearing potential:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year as outlined below.\n  * Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days and again within 24 hours prior to prescribing Revlimid(R) for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS(TM) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid(R). FCBP must also agree to ongoing pregnancy testing.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1% per year as noted below. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Contraception Requirements:\n\nPre-Treatment\u002FDuring Treatment:\n\n--All Drugs- Women- begins 28 days prior to treatment; Men- Begins on day 1\n\nPost-Treatment:\n\n* Venetoclax- Women- 90 days; Men 90 days\n* Ibrutinib- Women- 3 months; Men- 3 months\n* Obinutuzumab- Women- 18 months; Men- 6 months\n* Revlimid- Women-28 days; Men- 28 days\n\n  * All study participants must be registered into the mandatory Revlimid REMS(TM) program and be willing and able to comply with the requirements of Revlimid REMS(TM). NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program\n  * Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\n\n* Patients who are actively receiving any other investigational agents.\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\n* Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).\n\n  * Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin.\n  * Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\n* Strong CYP3A inhibitors\n* Strong CYP3A inducers\n\nNOTE: Moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible.\n\nUncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Uncontrolled and\u002For symptomatic thyroid disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1;\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with HBV or HCV:\n\n  --Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Patients with occult or prior HBV infection (defined as positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) with negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo HBV DNA testing during treatment and in surveillance for at least 12 months after completion of study therapy.\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women, or women who intend to become pregnant during the study, are excluded from this study because Revlimid(R) has known teratogenic effects and venetoclax, ibrutinib and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on study.\n* HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions with venetoclax, ibrutinib and Revlimid(R) and combination antiretroviral therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Evidence of active tumor lysis syndrome based on laboratory assessment\n* History of recent major surgery within 6 weeks prior to the start of Cycle 1, Day 1 other than for diagnosis\n* History of other active malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be eligible. Individuals in documented remission without treatment for greater than or equal to 2 years prior to enrollment may be included at the discretion of the investigator.\n* Known allergy to both xanthine oxidase inhibitors and rasburicase; or, known hypersensitivity to any of the study drugs","120 Years",{"count":561,"type":21},155,[59,24],"Background:\n\nB-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).\n\nObjective:\n\nTo study the safety of ViPOR for people with B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, urine, and heart tests\n* Tissue sample from previous procedure\n* Imaging scans\n* Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.\n\nParticipants will have a bone marrow aspiration before treatment.\n\nParticipants may have tumor samples taken.\n\nParticipants will get ViPOR in 21-day cycles. For up to 6 cycles:\n\n* Participants will get one drug by IV on days 1 and 2.\n* Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.\n\nParticipants will keep a drug diary.\n\nParticipants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.\n\nParticipants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.",[30,437,565,508],"Diffuse Large B-Cell Lymphoma",[211,567],"Dose-Finding","2026-06-16",{"date":544,"type":40},{"date":571,"type":40},"2018-02-09",{"date":573,"type":21},"2027-12-01",{"name":46,"class":47},{"id":576,"slug":4,"hasResults":11,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":11,"sex":16,"minAge":202,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":48},"100632395","NCT07513129","Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma","A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas","Inclusion Criteria:\n\n* Weight must be \\> or = to 40 kg\n* Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.\n* Age ≥ 12 year to ≤ 30 years.\n* Lansky ≥60 for patients \\\u003C16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)\n* Baseline ejection fraction must be \\> 40% OR Shortening fraction \\>20%. Either can be used at the investigator's discretion.\n* Adequate hepatic function (direct bilirubin \\\u003C 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 5x ULN unless considered due to leukemic involvement, in which case direct bilirubin \\\u003C 3x ULN or AST and\u002For ALT \\\u003C 10x ULN will be considered eligible.\n* Adequate renal function (calculated creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease as determined by PI.\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI.\n* Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n* Patients may have received any of the study agents prior to enrollment in study if not previously provided in study combination.\n* For patients with history or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.\n\nFor patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of active progression.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better as determined by PI.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion.\n\nExclusion Criteria:\n\n* Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n* No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions:\n\n  i. intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia.\n\nPrevious CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.\n\niii. use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.\n\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.\n* Patients with a concurrent second active malignancy under treatment.\n* Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n\nTesting is not required for patients without a known or suspected history.\n\n* Female subjects who are pregnant or breast-feeding.\n* Patient has an infection that is both active and uncontrolled.\n* History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.","30 Years",{"count":151,"type":21},[59],"This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL",[586,30],"T-cell Acute Lymphoblastic Leukemia","2026-06-15",{"date":544,"type":40},{"date":590,"type":40},"2026-06-05",{"date":592,"type":21},"2031-12-31",{"name":594,"class":97},"M.D. Anderson Cancer Center",{"id":596,"slug":4,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":4,"eligibilityCriteria":600,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":602,"briefSummary":603,"conditions":604,"keywords":607,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":48},"100641249","NCT07654426","The CARDIOPROTECT Trial","A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial","Inclusion Criteria:\n\n* Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.\n* Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.\n* Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \\\u003C18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants \\\u003C18 years of age; therefore, participants \\\u003C18 years of age are excluded from this study.\n* Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy\n\n  1. LVEF 30-50% on most recent echocardiogram with or without HF history\n  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).\n  3. History of anthracycline exposure for different malignancy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: \"Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs\" and NYHA Class IV defined as: \"Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased.\" (see Appendix A for NYHA Classification).\n* LVEF \\\u003C30% on most recent echocardiogram. Patients with prior LVEF \\\u003C30% with improvement to \\>30% on most recent echocardiogram are eligible.\n* Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.\n* Presence of central nervous system involvement\n* Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called \"double-hit\" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled\n* Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies\n* Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded\n* There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.\n* Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis\n* Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.\n* Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.\n* Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.",{"count":82,"type":21},[24],"This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.\n\nThe names of the study drugs involved in this study are:\n\n* Dexrazoxane (a type of Topoisomerase II Inhibitor)\n* Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)\n* Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)\n* Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab",[605,606,30],"Diffuse Large B-cell Lymphoma (DLBCL)","Cardiotoxicity",[605,608,606,30,609,610,611],"High Risk for Heart Failure Events","Stage B Heart Failure","Stage C Heart Failure","Left ventricular ejection fraction (LVEF) decline","2026-06-12",{"date":544,"type":40},{"date":615,"type":21},"2026-10-02",{"date":617,"type":21},"2035-12-31",{"name":619,"class":97},"Beth Israel Deaconess Medical Center",{"id":621,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":60,"conditions":624,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":73},"100616187",{"count":57,"type":21},[59,24],[62,63,30],"2026-06-10",{"date":612,"type":40},{"date":628,"type":21},"2026-06-30",{"date":69,"type":21},{"name":71,"class":72},{"id":632,"slug":4,"hasResults":11,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":648,"leadSponsor":650,"locationsCount":48},"100594042","NCT07014293","Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors","Inclusion Criteria:\n\n* English speaking adult (18 years or older at enrollment)\n* At least 6-months post-lymphoma diagnosis and within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy\u002Fimmunotherapy\u002Fradiation therapy, or other)\n\nExclusion Criteria:\n\n* Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician\n* Unwilling or unable to participate using telehealth platform",{"count":637,"type":21},254,[225],"The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.",[30],[642,643,644,645],"coping","psychosocial intervention","survivorship","resilience",{"date":612,"type":40},{"date":628,"type":21},{"date":649,"type":21},"2030-07-01",{"name":651,"class":97},"Massachusetts General Hospital",{"id":653,"slug":4,"hasResults":11,"nctId":654,"briefTitle":655,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":552},"100470233","NCT05403177","Marathon of Hope Cancer Centres Network Study for Ontario (MOHCCN-O)","MOHCCN-O","Inclusion Criteria:\n\n1. Patients with histological and\u002For cytological confirmation of blood or solid tumor malignancies. For tumour types where pre-surgical biopsy is not routinely performed to confirm a pathologic diagnosis of cancer, patients may consent to this protocol, but eligibility must be confirmed after pathology is finalized demonstrating presence of malignancy\n2. All patients must be able to satisfy the required minimum data elements for the 15k gold standard cohort through:\n\n   1. Already existing data that satisfies the minimal requirements of a gold standard case (refer to Table 1)\n   2. Have sufficient biospecimens (tumor and\u002For blood samples) available for more comprehensive molecular and immunophenotypic characterization\n3. Patients who do not satisfy the required minimum data elements but would like to participate, maybe requested to donate blood and undergo a fresh biopsy if the archived Formalin-fixed paraffin-embedded (FFPE) samples are not available, or in cases where a fresh tumor biopsy is deemed necessary for molecular profiling.\n4. Participating patients must agree to share their anonymized clinical and genomic data\n\nExclusion Criteria:\n\nNone.",{"count":659,"type":21},500,"The Marathon of Hope Cancer Centres Network (MOHCCN) is a national network of cancer centres that pursue collaborative cancer research in precision medicine (an emerging approach for disease treatment and prevention that considers individual variability in DNA, environment and lifestyle) to accelerate the discovery of innovations and improve the health outcomes for cancer patients",[662,663,664,665,666,667,668,29,30,669,670,671],"Breast Cancer","Colorectal Cancer","Pancreas Cancer","Kidney Cancer","Prostate Cancer","Ovary Cancer","Head and Neck Cancer","Lung Cancer","Melanoma","Solid Tumor","2026-06-09",{"date":625,"type":40},{"date":675,"type":40},"2022-06-23",{"date":677,"type":21},"2030-10",{"name":679,"class":97},"University Health Network, Toronto",{"id":681,"slug":4,"hasResults":11,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":48},"100507779","NCT05891821","Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed\u002FRefractory Lymphomas (IMMONC0001)","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving written informed consent\n2. ≥ 18 years of age\n3. Have a histologically confirmed diagnosis of a relapsed\u002Frefractory classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) for which no standard therapy is available or standard therapy has failed or the patient does not have access to it.\n4. Has a life expectancy of at least 3 months and an ECOG performance status of ≤1 as determined by study Investigator\n5. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated\n6. Has adequate organ function defined as the following laboratory values within 7 days of C1D1:\n\n   1. Neutrophils ≥ 1500\u002FμL (Must be stable and off any growth factor within 4 weeks of first study treatment administration)\n   2. Platelets ≥ 75 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   3. Hemoglobin ≥ 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   4. Creatinine clearance ≥ 30 mL\u002Fmin as measured or calculated per local institutional standards\n   5. AST\u002FALT ≤ 3 × upper limit of normal (ULN)\n   6. Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)\n7. Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 7 days before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):\n\n   1. ≥ 50 years of age and has not menstruated for greater than 1 year\n   2. Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation\n   3. WOCP must be willing to use highly effective methods of contraception (defined in the informed consent form \\[ICF\\]) throughout the study, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n8. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n9. Is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n1. Has an inadequate period of time prior to first dose of study treatment that is defined as:\n\n   1. Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment\n   2. Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter\n   3. Received small molecule\u002Ftyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter\n   4. Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment\n   5. Had major surgery within 4 weeks before initiation of study treatment\n2. Has gone through disease progression after receiving prior therapy with:\n\n   a. Any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies\n3. Has persisting AEs related to prior immunotherapy of NCI-CTCAE v5.0 Grade ≥ 2 severity.\n4. Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and\u002For surgical resection)\n5. Has known allergy or hypersensitivity to any component of balstilimab, any history of anaphylaxis, or uncontrolled asthma\n6. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.\n7. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n8. Has had an allogeneic tissue\u002Fsolid organ transplant\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n   a. QTcF (QTc interval corrected using Fridericia's formula) of \\> 480 ms.\n10. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.\n11. Has known untreated hepatitis B\u002Fhepatitis C virus (HBV\u002FHCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined by a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay\n12. Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n13. Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and\u002For interpretation of the current study\n14. Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the study\n15. Is legally incapacitated or has limited legal capacity\n16. Is pregnant or breastfeeding\n17. Has received a live\u002Fattenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment\n18. Has other co-morbidities that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)\n19. Is receiving other therapy that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)",{"count":57,"type":21},[24],"The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed\u002Frefractory lymphomas.\n\nParticipants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.",[30],"2026-06-04",{"date":691,"type":40},"2026-06-08",{"date":693,"type":40},"2023-09-01",{"date":695,"type":21},"2029-09",{"name":697,"class":97},"Immune Oncology Research Institute",{"id":699,"slug":4,"hasResults":11,"nctId":700,"briefTitle":701,"officialTitle":702,"acronym":703,"eligibilityCriteria":704,"healthyVolunteers":535,"sex":16,"minAge":705,"maxAge":706,"enrollmentInfo":707,"targetDuration":4,"studyType":22,"phases":709,"briefSummary":711,"conditions":712,"keywords":717,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":731,"lastUpdatePostDateStruct":732,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":48},"100565518","NCT06643221","Exercise as an Immune Adjuvant for Allogeneic Cell Therapies","Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies","Allo-X","Procedures are in place for protecting against or minimizing the risks to the healthy volunteers recruited for this study. Physical risk to volunteers and matched related donors will be protected through health screening to determine study eligibility, and medical monitoring with an established test termination criterion during the exercise and isoproterenol infusion trials.\n\nTo protect against the remote risk of an adverse cardiac event occurring during exercise and isoproterenol infusion, the study will only enroll volunteers who are considered \"low risk\" for maximal stress testing in accordance with the guidelines published by the American College of Sports Medicine (ACSM) and American Heart Association (AHA). Individuals who are considered \"low risk\" are men and women who are asymptomatic and have no more than one risk factor for cardiovascular disease (CVD). The risks to subjects are therefore extremely low. All infusions will take place in the Clinical and Translational Sciences Research Center (CATS) Infusion Suite, which is a designated University of Arizona campus facility for infusion trials and equipped with appropriate medical personnel and monitoring equipment (i.e. ECG). The graded exercise tests and isoproterenol infusions procedures will be performed under the direction of a licensed and board-certified cardiologist\n\nInclusion Criteria:\n\nParticipants must:\n\n* Be between 21 and 55 years of age.\n* Be classified as 'low-risk' for graded exercise\u002Fstress testing according to ACSM-AHA criteria.\n* Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Currently use tobacco products or have quit within the last 6 months.\n* Have a body mass index (BMI) greater than 34 kg\u002Fm² or waist circumference exceeding 102 cm for men and 88 cm for women.\n* Use any medications known to affect the immune system or regularly take ibuprofen\u002Faspirin, antidepressants, or medications that alter blood pressure or cardiovascular function.\n* Use of hormone replacement therapy.\n* Are pregnant or breastfeeding.\n* Have chronic or debilitating arthritis or have been bedridden in the past three months.\n* Experienced a common illness (e.g., colds) within the past 6 weeks.\n* Have central or peripheral nervous disorders, a history of stroke, or major affective disorder.\n* Are infected with HIV or hepatitis or have any autoimmune disease.\n* Have known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast.\n* Use any prescription medications or have an allergy to beta-blockers.\n* Have a resting heart rate of less than 50 beats per minute.\n* Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions.\n* Are scheduled for surgery.\n\nAdditionally, participants who meet the inclusion criteria but present with more than one of the following cardiovascular disease (CVD) risk factors will be excluded unless cleared by a cardiologist:\n\n* Family History: Myocardial infarction, coronary revascularization, or sudden death before 55 years of age in a father or male first-degree relative, or before 65 years of age in a mother or female first-degree relative.\n* Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg.\n* Dyslipidemia: Total serum cholesterol exceeding 200 mg\u002Fdl.\n* Pre-diabetes: Fasting blood glucose levels between 100 mg\u002Fdl and 126 mg\u002Fdl.","21 Years","55 Years",{"count":708,"type":21},200,[710],"EARLY_PHASE1","This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue.\n\nThis Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups:\n\n1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice.\n2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells.\n3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise.\n\nParticipants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.",[29,713,714,715,30,716],"Hematopoetic Stem Cell Transplantation","Donor Lymphocyte Infusion","CAR T-Cell Therapy","Cell Therapy",[237,718,719,720,721,722,723,724,725,726,727,728,729,730],"cell therapy","beta-blockers","immune function","phosphodiesterase inhibitor","CAR T-cells","NK-cells","cytokine-induced killer cells","cytokine-induced memory-like NK-cells","monoclonal antibodies","leukemia","lymphoma","donor lymphocyte infusion","gamma-delta T-cells","2026-06-03",{"date":590,"type":40},{"date":734,"type":40},"2018-01-24",{"date":736,"type":21},"2031-05-31",{"name":738,"class":97},"University of Arizona",{"id":740,"slug":4,"hasResults":11,"nctId":741,"briefTitle":742,"officialTitle":743,"acronym":4,"eligibilityCriteria":744,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":745,"targetDuration":4,"studyType":22,"phases":746,"briefSummary":747,"conditions":748,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":762,"lastUpdatePostDateStruct":763,"startDateStruct":764,"completionDateStruct":766,"leadSponsor":768,"locationsCount":48},"100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":21},[710],"This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[749,750,751,752,753,754,755,756,757,758,670,759,30,760,761],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Germ Cell Tumor","Endocrine Tumor","Glioma","2026-06-02",{"date":590,"type":40},{"date":765,"type":40},"2026-05-01",{"date":767,"type":21},"2028-05-01",{"name":769,"class":97},"University of California, Irvine",{"id":771,"slug":4,"hasResults":11,"nctId":772,"briefTitle":773,"officialTitle":774,"acronym":4,"eligibilityCriteria":775,"healthyVolunteers":11,"sex":16,"minAge":776,"maxAge":777,"enrollmentInfo":778,"targetDuration":4,"studyType":255,"phases":4,"briefSummary":780,"conditions":781,"keywords":792,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":762,"lastUpdatePostDateStruct":796,"startDateStruct":797,"completionDateStruct":799,"leadSponsor":800,"locationsCount":480},"100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":779,"type":21},30,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[782,29,30,783,16,784,517,496,520,785,786,438,787,231,508,788,789,790,791],"Hematologic Malignancy","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[793,794,795],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML",{"date":689,"type":40},{"date":798,"type":40},"2023-11-15",{"date":573,"type":21},{"name":801,"class":97},"Children's Hospital Medical Center, Cincinnati",""]