[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-acute-lymphoblastic-leukemia":374},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,60,71,94,121,132,156,178,202,225,251,282,303,320,352],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053688",false,"NCT06317662","Testing the Addition of the Anti-cancer Drug Venetoclax and\u002For the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321\n* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \\> 36 weeks gestational age at the time of enrollment\n* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \\[WHO\\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage\n\n  * Diagnostic immunophenotype: Leukemia cells must express CD19\n\nExclusion Criteria:\n\n* Patients with Down Syndrome\n* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy\n* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:\n\n  * Steroid pretreatment:\n\n    * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility\n    * Inhaled and topical steroids are not considered pretreatment\n    * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \\> 28 days before enrollment does not affect eligibility\n  * Intrathecal cytarabine or methotrexate:\n\n    * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility\n    * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status\n  * Hydroxyurea:\n\n    * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met","ALL","365 Days",{"count":18,"type":19},153,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial tests the addition of venetoclax and\u002For blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \\[R\\]) or without a KMT2A gene rearrangement (KMT2A-germline \\[G\\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and\u002For blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and\u002For blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.",[25,26],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2025-06-05",{"date":35,"type":19},"2028-12-31",{"name":37,"class":38},"National Cancer Institute (NCI)","NIH",113,{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":53,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100054157","NCT06124157","A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients must be \\> 365 days and \\\u003C 18 years (for AIEOP-BFM), \\> 365 days and \\\u003C 22 years (for Children's Oncology Group \\[COG\\]) and \\> 365 days and \\\u003C 46 years (for ALLTogether sites) at the time of enrollment\n* Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and\u002For dasatinib: ABL1, ABL2, CSF1R, and PDGFRB\n* Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment\n* Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and\u002For other standard cytotoxic chemotherapy\n* Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine\n* Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)\n* Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2\n  * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard\n* For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34.2 micromoles\u002FL) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)\n* \\* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) OR\n\n  * Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]) AND\n  * Corrected QT Interval, QTc \\\u003C 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\])\n\n    * Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment\n\nExclusion Criteria:\n\n* Known history of chronic myeloid leukemia (CML)\n* ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase\n* ALL developing after a previous cancer treated with cytotoxic chemotherapy\n* Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation\n* Down syndrome (trisomy 21)\n* Pregnancy and breast feeding\n\n  * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment\n  * Lactating females who plan to breastfeed their infants\n  * Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol\n\n    * NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer\n* Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib\n* Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","366 Days","46 Years",{"count":49,"type":19},222,[22],"This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes\u002Fcells\u002Fmolecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.",[26],{"date":30,"type":31},{"date":55,"type":31},"2025-05-30",{"date":57,"type":19},"2030-12-01",{"name":37,"class":38},154,{"id":61,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":62,"targetDuration":4,"studyType":20,"phases":63,"briefSummary":51,"conditions":64,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":70,"locationsCount":18},"100525624",{"count":49,"type":19},[22],[26],"2026-07-01",{"date":67,"type":31},"2026-07-02",{"date":55,"type":31},{"date":57,"type":19},{"name":37,"class":38},{"id":72,"slug":4,"hasResults":10,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100297337","NCT03150693","Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL","Inclusion Criteria:\n\nREGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n* Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \\>= 18 years and \\\u003C 40 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =\\\u003C 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance \\>= 50 mL\u002Fmin by Cockcroft-Gault\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized\n\n  * Rating: M0, M1; Blast Cells (%): 0-5.0\n  * Rating: M2; Blast Cells (%): 5.1-25.0\n  * Rating: M3; Blast Cells (%): \\> 25-50\n  * Rating: M4; Blast Cells (%): \\> 50.0\n  * The term \"blast cell\" includes any cell that cannot be classified as a more mature normal element, and includes \"leukemic cells,\" pathologic lymphocytes, and stem cells\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count \\>= 75,000\u002Fmm\\^3\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome\n* RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =\\\u003C 8 x upper limit of normal (ULN)\n\nEXCLUSION CRITERIA\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=\\\u003C 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\\\u003C 8 days prior to registration is required\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist","18 Years","39 Years",{"count":80,"type":19},303,[82],"PHASE3","This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \\[intervention\\], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.",[26],{"date":67,"type":31},{"date":87,"type":31},"2017-09-20",{"date":89,"type":19},"2027-08",{"name":91,"class":92},"Alliance for Clinical Trials in Oncology","OTHER",460,{"id":95,"slug":4,"hasResults":10,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":20,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100359362","NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.","25 Years",{"count":102,"type":19},5951,[82],"This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[26,106,107,108,109],"B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia","2026-06-18",{"date":112,"type":31},"2026-06-22",{"date":114,"type":31},"2019-10-31",{"date":116,"type":19},"2032-03-31",{"name":118,"class":119},"Children's Oncology Group","NETWORK",230,{"id":122,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":123,"targetDuration":4,"studyType":20,"phases":124,"briefSummary":23,"conditions":125,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":130,"leadSponsor":131,"locationsCount":39},"100540501",{"count":18,"type":19},[22],[25,26],"2026-06-10",{"date":128,"type":31},"2026-06-11",{"date":33,"type":31},{"date":35,"type":19},{"name":37,"class":38},{"id":133,"slug":4,"hasResults":10,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":10,"sex":15,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":20,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100642839","NCT07636564","Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment","A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)\u002F Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)","Inclusion Criteria:\n\n* COHORT A: Participants must meet diagnostic criteria for either B-cell acute lymphoblastic leukemia (ALL) with KMT2A-translocation or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation\n* COHORT A: Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT A: Participants must have achieved morphological first complete remission (CR1) after induction cycle (s) as defined bone marrow lymphoblasts \\\u003C 5%\n* COHORT A: Participants must have either known trackable clone(s) by clonoSEQ that was identified at initial diagnosis, or a banked diagnostic sample, which can include clinical samples from the treating institution, available that can be used to identify trackable clone(s)\n\n  * Participants must not be known not to have trackable clones by clonoSEQ\n  * Participants must not be known already to have MRD-negativity by clonoSEQ prior to enrollment\n* COHORT A: Participants must have evidence of CD19 expression at any level in ALL or ALAL documented locally by flow cytometry or immunohistochemistry in bone marrow or peripheral blood at the time of initial diagnosis. Immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage. Appropriate marker studies including CD19 (B cell) must be performed. If a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate Immunohistochemistry (IHC) testing, including CD19, must be performed on the bone marrow biopsy to determine lineage\n* COHORT A: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT A: Participants must not have known lymphoid blast crisis arising from chronic myeloid leukemia (CML) or have received previous tyrosine kinase inhibitor (TKI) therapy for their chronic myeloid leukemia (CML)\n* COHORT B: Participants must meet diagnostic criteria for either newly diagnosed with acute lymphoblastic leukemia (ALL) or acute leukemia with ambiguous lineage (ALAL)\n\n  * Participants with either B or T-cell subtypes of ALL are permitted on Cohort B\n  * Participants must have KMT2A-translocation documented locally by conventional cytogenetics, fluorescence in situ hybridization (FISH) or molecular studies such as next generation sequencing (NGS)\n* COHORT B: Participants must have Philadelphia-chromosome negative ALL or ALAL\n* COHORT B: Participants must not have known lymphoid blast crisis arising from CML or have received previous TKI therapy for their chronic myeloid leukemia (CML)\n* COHORT A: Participants ≥ 18 years may have received 1 to 3 cycles of induction\u002Fconsolidation before entering the study. It is encouraged to enroll participants immediately after completing the first induction cycle if the patient achieves morphological CR. For pediatric patients \\\u003C 18 years of age, enrollment must occur after induction therapy\n* COHORT A: Participants must discontinue strong cytochrome P450 (CYP)3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT A: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT A: Participants must not be receiving any oral or intravenous systemic immunosuppressive therapy with the exception of induction\u002Fconsolidation chemotherapy for the treatment of their current ALL or ALAL. Participants may receive up to 10 mg per day of prednisone or prednisone equivalent for adrenal insufficiency or other indications\n* COHORT A: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participants must not have received prior blinatumomab, menin inhibitors, chimeric antigen receptor (CAR)-T therapy, or anti-CD19 antibodies\n* COHORT B: Participants must not have received prior systemic therapy for ALL or ALAL, with the exception of hydroxyurea, steroid, retinoic acid, intrathecal chemotherapy, or induction chemotherapy as defined below\n\n  * Participants who have been started on the study regimen backbone (i.e. induction therapy) before consenting and then are found to have the KMT2Ar and are eligible for the study, can be enrolled on the study as long as revumenib treatment can be started by day 8 of induction therapy\n* COHORT B: Participants must discontinue strong CYP3A4 inhibitors or strong or moderate inducers, except corticosteroids, within 14 days prior to registration\n* COHORT B: Participants must have recovered from any prior major surgery adverse effects at least 14 days prior to registration, to the satisfaction of the local investigator\n\n  * Note: Central venous access placement is not considered major surgery for the purposes of this protocol\n* COHORT B: Participants must not be receiving any systemic oral or intravenous immunosuppressive therapy with the exception of induction chemotherapy or corticosteroid for the treatment of their current ALL or ALAL\n* COHORT B: Participants must not have received a prior allogeneic hematopoietic stem cell transplant\n* COHORT A: Participant must be ≥ 1 years old at the time of registration. There is no upper age limit\n* COHORT A: Participant must have Zubrod\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Lansky\u002FKarnofsky performance status scores of 50-100\n* COHORT A: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT A: Glomerular filtration rate (GFR) ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT A: Absolute neutrophil count ≥ 1 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Platelets ≥ 100 x 10\\^3\u002FuL (within 14 days prior to registration)\n* COHORT A: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have direct bilirubin ≤ 5 x institutional upper limit of normal (ULN)\n* COHORT A: Alanine aminotransferase (ALT) ≤ 5 x institutional ULN (within 14 days prior to registration)\n* COHORT A: Participants ≥ 18 years must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT A: Adequate renal function for participants \\\u003C 18 years of age is defined as:\n\n  * A GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2, as determined by one of the following methods:\n\n    * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009)\n    * Measured GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard)\n* COHORT A: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2 dimensional (2-D) echocardiogram or shortening fraction (SF) ≥ 27% by echocardiogram within 90 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT A: Participants ≥ 18 years of age with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT A: Participants ≥ 18 years of age with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants ≥ 18 years of age with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT A: Participants must not have prolonged Fridericia's formula-corrected QT interval (QTcf) defined as \\> 450 msec on screening electrocardiogram (EKG) prior to registration\n* COHORT A: Participants must not have relapsed or refractory disease in the bone marrow (≥ 5% blasts) or extramedullary sites involvement\n* COHORT A: Participants must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator\n* COHORT A: Participants must not have clinically significant autoimmune disease\n* COHORT A: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via nasogastric\u002Fgastrostomy (NG\u002FG)-tube is acceptable as long as oral solution is used\n* COHORT A: Participants must not have uncontrolled intercurrent illness including, but not limited to:\n\n  * Active central nervous system status 3 (CNS3) or CNS2 (CNS leukemia)\n\n    * Note: Participants with CNS1 or who had prior CNS2 or CNS3 are eligible if this has cleared and have become CNS-1\n  * Currently requiring supplemental oxygen (more than 2 liters per minute), mechanical ventilation, vasopressors\n* COHORT A: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT A: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* COHORT B: Participant must be ≥ 55 years old at the time of registration\n* COHORT B: Participant must have Zubrod\u002FECOG performance status of 0-2\n* COHORT B: Participants must have a complete medical history and physical exam within 28 days prior to registration\n* COHORT B: GFR ≥ 50 ml\u002Fmin\u002F1.73 m\\^2 (within 14 days prior to registration)\n* COHORT B: Direct bilirubin ≤ 2.0 mg\u002FdL (34.2 micromoles\u002FL) (within 14 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease or elevated bilirubin is related to underlying leukemia must have direct bilirubin ≤ 5 x institutional ULN\n* COHORT B: ALT ≤ 5 x institutional ULN unless abnormal liver tests are related to underlying leukemia (within 14 days prior to registration)\n* COHORT B: Participants must have a calculated creatinine clearance ≥ 50 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 14 days prior to registration\n* COHORT B: Participants must have adequate cardiac function. Participants must have cardiac ejection fraction ≥ 50% by MUGA or 2-D echocardiogram within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* COHORT B: Participants with a known history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* COHORT B: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* COHORT B: Participants must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration. Intrathecal cytarabine and\u002For methotrexate administered prior to study registration may count as the first dose of intrathecal therapy required as part of protocol therapy\n* COHORT B: Participants must not have an active uncontrolled infection\n* COHORT B: Participants must not have prolonged QTcf defined as \\> 450 msec participants on screening EKG prior to registration\n* COHORT B: Participants must not have known clinical signs of bulk central nervous system involvement (CNS3c), such as facial palsy, brain\u002Feye involvement or hypothalamic syndrome\n* COHORT B: Participants must be able to take oral medications and comply with the oral regimen Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications. Administration via NG\u002FG-tube is acceptable as long as oral solution is used\n* COHORT B: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* COHORT B: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n\n  * Note: Participants of childbearing potential must have a negative pregnancy test within 7 days prior to starting treatment\n* ALL COHORTS: Participants must be offered the opportunity to participate in specimen collection submitted for translational medicine work. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n  * This trial will use a slot reservation system to enroll the feasibility and safety run-in portions of the study for Cohort A and Cohort B. Patients planning to enroll at this portion of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation","1 Year",{"count":140,"type":19},90,[22],"This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.",[25,26,144,145],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-06-03",{"date":149,"type":31},"2026-06-09",{"date":151,"type":19},"2026-10-14",{"date":153,"type":19},"2032-04-16",{"name":155,"class":119},"SWOG Cancer Research Network",{"id":157,"slug":4,"hasResults":10,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":10,"sex":15,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":20,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100276361","NCT02877303","Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia","Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia","Inclusion Criteria:\n\n* Patients with newly diagnosed, previously untreated B-lineage ALL or lymphoblastic lymphoma, or having achieved complete remission (CR) with one course of induction chemotherapy; patients who require steroids, cytarabine (ara-c) or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible\n* Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible\n* Performance status of 0-3\n* Creatinine less than or equal to 2.0 mg\u002FdL (unless considered tumor related)\n* Bilirubin less than or equal to 2.0 mg\u002FdL (unless considered tumor related)\n* Adequate cardiac function as assessed by history and physical examination\n* No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Known to be human immunodeficiency virus (HIV)-positive\n* Philadelphia chromosome (Ph)-positive ALL\n* Active and uncontrolled disease\u002Finfection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n* Unable or unwilling to sign the consent form\n* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per treating physician assessment), sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n* History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; (Patients with CNS involvement of leukemia are NOT excluded)\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences\u002Fmanifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar disease, or psychosis","14 Years",{"count":164,"type":19},80,[22],"This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.",[26,106],"2026-05-18",{"date":170,"type":31},"2026-05-20",{"date":172,"type":31},"2016-11-01",{"date":174,"type":19},"2026-11-01",{"name":176,"class":92},"M.D. Anderson Cancer Center",1,{"id":179,"slug":4,"hasResults":10,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":20,"phases":187,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":177},"100634432","NCT07539610","Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors","Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors: A Prospective, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Patients aged ≥18 and \\\u003C70 years, of any gender;\n* diagnosed with B-ALL\u002FLBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);\n* meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression;\n* At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and\u002For extramedullary lesions;\n* Meeting the diagnosis of relapsed\u002Frefractory B-ALL\u002FLBL, including any of the following situations: a. Primary refractory patients who have not achieved complete remission after two cycles of standardized chemotherapy or patients who have not achieved complete remission after multiple salvage chemotherapy regimens; b. Patients who relapse within 12 months after achieving complete remission or relapse after 12 months of achieving complete remission and have not achieved complete remission after one or more courses of standard treatment induction; c. Patients who relapse after hematopoietic stem cell transplantation or after CAR-T therapy targeting the same target;\n* Other relapsed\u002Frefractory CD19 weakly expressing hematological malignancies;\n* Creatinine clearance rate \\> 60 ml\u002Fmin (Cockcroft and Gault formula); for patients without liver involvement, total serum bilirubin \\\u003C 3 times the upper limit of normal, and both serum ALT and AST \\\u003C 5 times the upper limit of the normal range.\n* Echocardiography shows left ventricular ejection fraction (LVEF) of 250%;\n* Finger pulse oxygen saturation \\> 92%;--Estimated survival period of more than 3 months;\n* Estimated survival period of more than 3 months;\n* ECOG score of 0-2;\n* The subject or his\u002Fher legal guardian voluntarily participates in this trial and signs the informed consent form.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL);\n* presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;\n* uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;\n* prior administration of antineoplastic therapy before infusion; exclusion criteria include: a. Received systemic chemotherapy within 1 week (excluding pre-treatment); b. Those who have received monoclonal antibody treatment, with the time from the last monoclonal antibody infusion to the screening being less than 5 half-lives or 4 weeks (whichever is shorter); c. Received donor lymphocyte infusion (DLI) within 6 weeks;\n* Had uncontrolled severe active infection at screening;\n* Had a history of severe heart disease, including: severe heart dysfunction (according to the New York Heart Association (NYHA) cardiac function classification criteria, subjects with grade III or V cardiac dysfunction), myocardial infarction within 12 months or undergoing coronary angioplasty or stent placement, unstable angina pectoris, or electrocardiogram indicating a significantly prolonged QT interval (\\>480ms) or the investigator determined severe arrhythmia;\n* Had a history of head trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, or cerebrovascular hemorrhagic disease, and required medication within the past 6 months;\n* Had hepatitis B surface antigen (HBsAg) greater than 10E6 IU\u002FmL at screening; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; EBER positive or EBV copy number \\> upper limit of normal;\n* Those who require the use of steroid hormones during CAR-T infusion (except for those using inhaled steroid hormones locally); subjects who are receiving systemic steroid treatment before screening and whose study investigators determine that they need long-term systemic steroid treatment during the treatment period (excluding those using inhaled or local steroid hormones);\n* Subjects with treatable autoimmune diseases, immunodeficiency or those requiring immunosuppressive therapy;\n* Subjects who had acute graft-versus-host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening;\n* Subjects with a history of allergy to any component of the cell product;\n* Pregnant or lactating women, as well as male or female subjects who have reproductive capacity and cannot take effective contraceptive measures within 1 year after cell infusion (regardless of gender); male subjects who plan to conceive within 1 year after cell infusion; female subjects or their partners who plan to conceive within 1 year after cell infusion;\n* Any situation that the investigator considers may increase the risk for the subject or interfere with the test results.","69 Years",{"count":186,"type":19},9,[188],"PHASE1","Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research",[191,192],"B-Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia\u002FLymphoma","2026-04-13",{"date":195,"type":31},"2026-04-20",{"date":197,"type":19},"2026-04",{"date":199,"type":19},"2027-11",{"name":201,"class":92},"Institute of Hematology & Blood Diseases Hospital, China",{"id":203,"slug":4,"hasResults":10,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":20,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":177},"100570682","NCT06710418","Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma\u002FLeukemia","Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of \"high-grade\" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia \\[APL\\]) or B-cell acute lymphoblastic lymphoma\u002Fleukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis\n* Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as \"7+3,\" hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone \\[CVAD\\], or regimen with cytarabine backbone ≥ 1,000mg\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)\n* Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL\n* Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL\n* Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization\n* Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy\u002FHSCT\n* Patients requiring renal replacement therapy at the time of randomization\n* Patients who decline transfusion for personal or religious beliefs\n* Pregnancy or lactation",{"count":209,"type":19},50,[211],"NA","This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma\u002Fleukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and\u002For anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the \"minimum\" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\\> 7 gm\u002FdL) compared to a more liberal hemoglobin threshold (\\> 9 gm\u002FdL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.",[214,26,106,215],"Acute Myeloid Leukemia","Myeloid Neoplasm","2026-02-09",{"date":218,"type":31},"2026-02-12",{"date":220,"type":31},"2025-10-15",{"date":222,"type":19},"2027-12-31",{"name":224,"class":92},"University of Washington",{"id":226,"slug":4,"hasResults":10,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":20,"phases":233,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":177},"100611341","NCT07239323","In VIVO CAR-T Therapy for Relapsed\u002FRefractory Hematological Malignancies","Intracellularly Prepared Chimeric Antigen Receptor T-cell Therapy Targeting CD19 for the Treatment of Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender unrestricted;\n2. Confirmed diagnosis of relapsed\u002Frefractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;\n3. ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;\n4. Blood routine test results during the screening period meet the following criteria:\n\n   ① Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g\u002FdL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g\u002FdL;\n   * Absolute neutrophil count (ANC) ≥ 600\u002FμL (no use of granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000\u002FμL; ④ Lymphocyte count ≥ 500\u002FμL;\n5. Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n6. Liver function during the screening period meets the following criteria:\n\n   ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN;\n\n   ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin can be relaxed to ≤ 1.5 × ULN);\n7. Cardiac function during the screening period meets the following criteria:\n\n   ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan);\n\n   ② No clinically significant pericardial effusion;\n\n   ③ No clinically significant electrocardiogram (ECG) abnormalities;\n8. Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;\n9. Women of childbearing age must have a negative pregnancy test during the screening period and before drug administration, and must not be in the lactation period;\n10. Men and women of childbearing age must agree to take effective contraceptive measures and not donate reproductive cells (including sperm or eggs) from the time of signing the informed consent form until 1 year after the end of study drug administration;\n11. The subject or their legally authorized representative has signed the informed consent form (ICF), indicating their understanding of the purpose and procedures of the study and their voluntary participation in this study.\n\nExclusion Criteria:\n\n1. Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):\n\n   ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;\n\n   ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);\n2. History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;\n3. History of other malignant tumors (except for this disease), except for the following situations:\n\n   ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;\n\n   ② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;\n4. Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;\n5. Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;\n6. Clinically significant cardiac diseases:\n\n   * Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);\n\n     * Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) \u002F coronary artery stent implantation within 6 months before signing the informed consent;\n\n       * Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;\n7. Other clinically significant diseases, including but not limited to:\n\n   * Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;\n\n     * Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;\n8. Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);\n9. Had received live attenuated vaccines within 1 month before administration;\n10. Had a history of severe allergic reactions to this product or its formulation components;\n11. Patients who were not suitable for establishing intravenous access;\n12. The investigator believed that there were other conditions that made the patient unsuitable for participating in this study.",{"count":232,"type":19},24,[188],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.",[191,236,237],"B Cell Non-Hodgkin's Lymphoma","Multiple Myeloma",[239,240,241],"in Vivo","CAR-T","malignant hematological tumors","2025-11-16",{"date":244,"type":31},"2025-11-20",{"date":246,"type":31},"2025-07-01",{"date":35,"type":19},{"name":249,"class":250},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",{"id":252,"slug":4,"hasResults":10,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":10,"sex":15,"minAge":138,"maxAge":100,"enrollmentInfo":258,"targetDuration":4,"studyType":20,"phases":259,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":177},"100570128","NCT06703216","Pre-emptive Anakinra for Cytokine Event Reduction","Pilot Study of Pre-emptive Anakinra for the Prevention of Severe Cytokine Release Syndrome in Children and Young Adults With B-Acute Lymphoblastic Leukemia Receiving Chimeric Antigen Receptor (CAR) T Cells","PACER","• Patient consent and parental assent will be obtained.\n\nNOTE: Signed consent form must be obtained prior to any study procedures. Labs, marrows or other procedures obtained during routine clinical care maybe used for eligibility if obtained within the protocol required windows.\n\n* Patients or their parents\u002Flegally authorized representatives (LARs) must have the ability to understand and the willingness to sign a written informed consent document.\n* The effects of Anakinra on the developing human fetus are largely unknown. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 90 days following completion of Anakinra therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n\nNote: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Patients who are between the age of 1 to 26 years\n* Relapsed or refractory B-acute lymphoblastic leukemia\n\n  * 2nd or greater marrow relapse OR\n  * Central nervous system (CNS) relapse OR\n  * Any relapse after allogeneic hematopoietic stem cell transplant (HSCT) OR\n  * Refractory disease defined by not achieving an minimal residual disease (MRD)-negative complete remission (CR) after ≥ 2 chemotherapy cycles (1 cycle for relapsed patients) OR\n  * Ineligible for allogeneic HSCT because of:\n\n    * Comorbid disease\n    * Other contraindications to allogeneic HSCT conditioning\n    * No suitable donor\n    * Prior HSCT\n    * Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, about the role of HSCT with a HSCT physician\n  * Documentation of CD19+ tumor expression in the bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry at relapse, or a recent sample in the case of refractory disease. If the patient has received CD19-directed Pre-emptive anakinra for severe CRS prevention therapy, the flow cytometry should be obtained after this therapy to show CD19 expression.\n* Adequate organ function defined as:\n\n  * Alanine aminotransferase (ALT) \\\u003C 500 U\u002FL\n  * Bilirubin ≤2.0 mg\u002FdL\n  * Minimum pulmonary reserve defined as ≤Grade 1 dyspnea, pulse oximetry \\>92% on room air; diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (corrected for anemia) if pulmonary function tests (PFTs) are clinically appropriate as determined by the treating investigator.\n  * Left ventricular shortening fraction ≥ 28% or ejection fraction ≥40% confirmed by echocardiography (ECHO), or adequate ventricular function documented by imaging or a cardiologist.\n  * Serum creatinine below the values in the below table, based on age\u002Fsex assigned at birth: Maximum Serum Creatinine (mg\u002FdL) Age (years) Male Female 1 to \\\u003C2 0.6 0.6 2 to \\\u003C6 0.8 0.8 6 to \\\u003C10 1.0 1.0 10 to \\\u003C13 1.2 1.2 13 to \\\u003C16 1.5 1.4 ≥16 1.7 1.4\n* Bone marrow disease burden of ≥5% or peripheral blasts within 2 weeks of the start of lymphodepleting chemotherapy\n* Receiving commercially available tisagenlecleucel",{"count":232,"type":19},[188,22],"Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell therapy for B-acute lymphoblastic leukemia (B-ALL) in children and young adults.\n\nPatient Population: Children and young adults \\\u003C25 years of age undergoing CAR T-cell therapy for B-ALL with bone marrow disease burden of ≥5% involvement or detectable peripheral blasts within 2 weeks of the initiation of lymphodepleting chemotherapy.\n\nStudy Design: This is a pilot single arm study. The investigators will inquire into the efficacy and safety of using anakinra pre-emptively to reduce the rate of severe CRS in patients with \\>\u002F=5% bone marrow blasts or lymphoblasts in the peripheral blood.\n\nTreatment Plan:\n\nThis is a single arm unblinded study in which patients will receive anakinra, 2.5 mg\u002Fkg (max 100mg), IV every 12 hours starting at the onset of persistent fever (fever \\>38.5⁰ C x 2 occurrences separated by at least 4 hours in a 24 hour period). If there is persistence or progression of CRS, anakinra frequency will be increased to 2.5mg\u002Fkg IV (max 100mg), every 6 hours. Anakinra will be continued until 48 hours after resolution of CRS and ICANS, and at least 7 days post-CAR T infusion. If dose and frequency of anakinra is increased, the increased dose of anakinra will be continued until 48 hours after resolution of CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) and at least 7 days post-CAR T infusion. For CRS worsening beyond dose escalation of anakinra, CRS will be managed as per standard of care management. Participants will be followed for 12 months following enrollment in the study and disease evaluations will be performed as per routine clinical care following CAR T-cell therapy.",[191,262,263,264,265],"CAR-T Cell Therapy","Cytokine Release Syndrome","Immune Effector Cell Associated Neurotoxicity Syndrome","Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome",[267,263,268,269,270,271,272,264],"Anakinra","CAR-T Therapy","Pediatric","B-acute lymphoblastic leukemia","Prophylaxis","Inflammatory Toxicity","2025-06-12",{"date":275,"type":31},"2025-06-15",{"date":277,"type":19},"2025-08",{"date":279,"type":19},"2030-02-28",{"name":281,"class":92},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":283,"slug":4,"hasResults":10,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":10,"sex":15,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":20,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":177},"100588404","NCT06940960","JY231(JY231) Injection for the Treatment of Relapsed\u002FRefractory B Cell Lymphoma\u002F Leukemia","An Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 12-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   1. Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   2. Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   3. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;\n   4. In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    1. Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    2. Grass aminotransferase (AST) ≤3 times ULN;\n    3. Total bilirubin ≤1.5 times ULN;\n    4. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    5. Indoor oxygen saturation ≥ 92%;\n    6. Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    7. There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    1. Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    2. Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    3. Platelet≥50.000\u002Fmm3;\n    4. Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    1. Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    2. Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    3. Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    4. Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    5. CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    1. Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    2. Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    3. The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n16. Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.","12 Years","75 Years",{"count":291,"type":19},20,[211],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002F leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[26,295],"B-Non Hodgkin Lymphoma",{"date":297,"type":31},"2025-06-10",{"date":55,"type":31},{"date":300,"type":19},"2027-12",{"name":302,"class":92},"Affiliated Hospital of Guangdong Medical University",{"id":304,"slug":4,"hasResults":10,"nctId":305,"briefTitle":285,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":289,"enrollmentInfo":308,"targetDuration":4,"studyType":20,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":318,"locationsCount":177},"100584494","NCT06890065","An Early-Phase Exploratory Clinical Study of JY231 Injection in Relapsed\u002FRefractory B-Cell Lymphoma\u002FLeukemia: Safety, Tolerability, and Preliminary Efficacy","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n\n16）Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.",{"count":291,"type":19},[211],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002Fleukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[26,295],"2025-05-12",{"date":314,"type":31},"2025-05-15",{"date":316,"type":31},"2025-03-01",{"date":300,"type":19},{"name":319,"class":250},"Shenzhen Genocury Biotech Co., Ltd.",{"id":321,"slug":4,"hasResults":10,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":20,"phases":329,"briefSummary":330,"conditions":331,"keywords":340,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":177},"100460913","NCT05281809","Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia","A Feasibility Study Following a Phase 2a Design to Demonstrate Successful Local Manufacture of Chimeric Antigen Receptor (CAR) T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Subjects with CD19+ B-cell lymphoma or B-Cell Acute Lymphoblastic Leukemia (B-ALL) with no currently available curative treatment option (such as autologous or allogeneic Hematopoietic stem cell transplantation (HSCT)) who have a limited prognosis (\\\u003C2-year projected survival) will be enrolled. Participation on this trial is permitted as a bridge to HSCT.\n2. Peripheral blood CD3 count \\> 200\u002FµL by flow cytometry. Please note that this test might need to be repeated multiple times as standard practice to optimize collection efficiency.\n3. Subjects will have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), CLL, Marginal Zone Lymphoma (MZL), Lymphoplasmacytic Lymphoma (LPL) or B-ALL and will have failed at least 2 lines of therapy in the case of lymphoma and one line if the diagnosis is B-ALL or be refractory (no response or progressive disease) to first line therapy. A line of therapy must include conventional (immuno) chemotherapy (e.g. rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHOP) or Bendamustine plus Rituximab (BR) in the case of lymphoma) administered for at least 2 cycles. Second or greater lines of therapy must be administered for at least two cycles. Single agent anti-CD20 monoclonal antibody (e.g. rituximab, obinutuzumab) is not considered for the purposes of these criteria to count as a line of therapy. The definition of a line of therapy is taken according to recommended regimens for first and second line therapy in the relevant sections of the National Comprehensive Cancer Network (NCCN) guidelines. The most recent version of the guidelines will be used for eligibility determination. In the unlikely event that a subject received a first or second line regimen no longer listed in the most recent guidelines, but previously present in the version of the guidelines active at the time the therapy was administered, then the subject would be deemed to have received a line of therapy.\n4. Subjects with pathological and clinical evidence of transformed indolent lymphoma (FL, CLL, MZL or LPL) are eligible for participation on this trial if they have received at least one line of therapy for transformed disease for at least two cycles regardless of response.\n5. Demonstration of CD19 expression by immunohistochemistry or flow cytometry on a pathological specimen of lymphoma or ALL cells at any time in the course of prior treatment.\n6. Subjects who are unable to receive commercially available CD19-CAR T-cell therapy.\n7. Patients with lymphoma must have measurable or assessable disease. Patients in complete remission with no evidence of disease are not eligible.\n8. Patients with B-ALL must have at least measurable detectable disease on two separate occasions at least 2 weeks apart to be eligible.\n9. Subjects who relapse at \\> 100 days after autologous or allogeneic HSCT are eligible for participation on this trial. Allogeneic HSCT recipients must be off all immunosuppression for a minimum of 4 weeks before leukapheresis is performed and be free of active acute and chronic Graft Versus Host Disease (GVHD).\n10. Subjects will be ≥ 18 and \\\u003C 80 years of age.\n11. Female subjects of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive. Active contraception should continue for at least one year after CAR T-cell infusion.\n12. Male participants must be willing to practice birth control from the time of enrollment on this study and for 6 months after receiving the preparative regimen.\n13. Cardiac ejection fraction ≥ 0.45 by MUGA (multigated acquisition) or echocardiography.\n14. No requirement for supplemental oxygen and no dyspnea at rest. DLCO (diffusing capacity of the lungs for carbon monoxide) and FEV (forced expiratory volume)1 ≥ 0.65 of predicted.\n15. Karnofsky performance score ≥ 70.\n16. Subjects must have an expected survival \\> 12 weeks.\n17. Subjects must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate.\n18. Subjects must consent to anonymous reporting of data to the CIBMTR (Center for International Blood and Marrow Transplant Research).\n\nExclusion Criteria:\n\n1. Infection with HIV (human immunodeficiency virus) and active viral replication. Patients with an undetectable viral load on ART (antiretroviral treatment) can be considered for participation on this protocol.\n2. Infection with hepatitis B and active viral replication.\n3. Infection with hepatitis C and active viral replication.\n4. Active untreated CNS (central nervous system) leukemia or lymphoma. Patients with treated CNS leptomeningeal or parenchymal disease might be eligible if the CNS disease is inactive. The CSF (cerebrospinal fluid) must be clear on two separate occasions at least 4 weeks apart. Brain imaging must demonstrate no evidence of progressive disease on two separate occasions at least 4 weeks apart.\n5. Active bacterial, fungal or viral infection.\n6. Concurrent second malignancy requiring active therapy. Patients with breast or prostate cancer stable on hormonal therapy might be considered for participation if otherwise unimpaired.\n7. Documented myocardial infarction within 6 months of study participation and\u002For symptomatic coronary artery or valvular disease or uncontrolled arrhythmia.\n8. Investigational drug use within 30 days before leukapheresis.\n9. Anti-cancer therapy administration within 4 weeks of leukapheresis including antiCD19 directed therapy, monoclonal antibody therapy, bi-specific T-cell engager therapy and targeted therapy such as Abelson tyrosine kinase inhibitors, Bruton's tyrosine kinase inhibitors, venetoclax and Lenalidomide or other IMiD (Immunomodulatory Drug).\n10. Involved field radiation therapy is permitted if it terminates at least 15 days before leukapheresis and associated toxicity is grade 2 or less. Radiation therapy within 14 days of leukapheresis would make the subject ineligible.\n11. Checkpoint inhibitor therapy within 4 weeks before leukapheresis.\n12. Corticosteroid therapy at pharmacological dose (\\> 10 mg of prednisone or biological equivalent) within 4 weeks before leukapheresis.\n13. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to leukapheresis as deemed by the prescribing physician.\n14. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease:\n\n    AST (Aspartate transaminase)\u002FSGOT(serum glutamic-oxaloacetic transaminase) \\> 2.0 times the upper limit of normal ALT (alanine aminotransferase)\u002FSGPT (serum glutamic-pyruvic transaminase) \\> 2.0 times the upper limit of normal Total bilirubin \\> 2.0 times the upper limit of normal, unless subject has Gilbert's Syndrome (\\>3.0 times the upper limit of normal) Hemoglobin \\\u003C 8 gm\u002FdL or dependent upon transfusion to maintain ≥ 8 gm\u002FdL White blood cell count \\\u003C 2,000\u002Fmm3 Platelet count \\\u003C 50,000\u002Fmm3 or dependent upon transfusion to maintain ≥ 50,000 mm Creatinine \\> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL\u002Fmin.\n15. Pregnant or lactating females.\n16. Subjects who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures.\n17. Subjects who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures.","79 Years",{"count":328,"type":19},30,[22],"This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.",[332,26,333,334,335,336,337,338,339],"B-Cell Lymphoma","Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Chronic Lymphocytic Leukemia","Transformed Lymphoma",[341,342],"CAR T-cell","CD19 (cluster of differentiation antigen) 19","2025-01-10",{"date":345,"type":31},"2025-01-13",{"date":347,"type":31},"2022-04-19",{"date":349,"type":19},"2037-12-01",{"name":351,"class":92},"John Lister",{"id":353,"slug":4,"hasResults":10,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":10,"sex":15,"minAge":138,"maxAge":100,"enrollmentInfo":358,"targetDuration":4,"studyType":20,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100463123","NCT05310591","Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence","CAPTiRALL","Inclusion Criteria:\n\n* Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd relapse or later, refractory ALL).\n* Patient must have a second tisagenlecleucel (Kymriah ®) product available\n* Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes \\\u003C 10 \u002Fmm3 and\u002F or \\\u003C 3% of total lymphocytes (\\\u003C 6 months after infusion) while still being in CR with undetectable MRD\n* Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes \\\u003C 10 \u002Fmm3 and\u002F or \\\u003C 3% of total lymphocytes and a CD19+ ALL detectable disease in the marrow and\u002For Blood\n* Life expectancy \\> 12 weeks.\n* Karnofsky (age \\> 16) Lansky (age \\\u003C 16) \\> 70 at screening.\n* No organ dysfunction\n* Who have signed an informed consent\n* Affiliation to social security or any health insurance (as a beneficiary or assignee)\n\nExclusion Criteria:\n\n* Patient has received intervening therapy for leukemia after first tisagenlecleucel infusion (chemotherapy, anti leukemic immunotherapy, ITK, allogeneic HSCT).\n* Patient has an active autoimmune disease requiring systemic treatment within the past 2 years.\n* Patient has known history of, or any evidence of active, non-infectious pneumonitis.\n* Patient has a history of non-infectious pneumonitis that required steroid or has current pneumonitis.\n* Had receive prior therapy with an anti-PD1, Anti- PDL1 or anti-PDL2 agent.\n* Patient has hypersensivity to pembrolizumab\u002F nivolumab or one of its excipients\n* Patient has received a live vaccine injection within 45 days of planned start of study therapy.\n* Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.\n* Patients with Burkitt's lymphoma\u002Fleukemia\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n* Prior treatment with any gene therapy product except first tisagenlecleucel (Kymriah ®) injection.\n* Prior treatment with any anti-CD19\u002Fanti-CD3 therapy, or any other anti-CD19 therapy, except for patients pre-treated with blinatumomab and\u002For tisagenlecleucel (Kymriah®)\n* Prior anti-cancer monoclonal antibody within 4 weeks before starting the study.\n* Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade1 or at baseline) from adverse events due to a previously administered agent.\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of Screening), or any uncontrolled infection at Screening.\n* Human immunodeficiency virus (HIV) positive test within 8 weeks of Screening.\n* Presence of grade 2 to 4 acute or extensive chronic GVHD.\n* Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible.\n* Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening.\n* Previous or concurrent malignancy with the following exceptions:\n\n  * Adequately treated basal cell or squamous cell carcinoma\n  * in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study.\n  * A primary malignancy completely resected and in CR for ≥ 5 years\n* Pregnant or lactating women (female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion)\n* Patient with hypersensivity to Fludarabine and\u002For cyclophosphamide and\u002For tisagenlecleucel and\u002For nivolumab or one of their excipients.",{"count":359,"type":19},26,[188,22],"Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow\u002F peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the CAR T-cells, is associated to a very high risk of relapse. A reinfusion of CTL019, even after Fludarabine-Cyclophosphamide reconditioning, frequently fails to induce further expansion as observed in UPENN studies and in the Robert Debré Hospital experience.\n\nNon-persistence of CAR T-cells may be due to immune- mediated rejection or environment-mediated suppression of their growth. Evidence for increased PD-1 expression in CAR T-cells between infusion and peak expansion has been demonstrated in clinical samples.\n\nPreclinical data and few clinical data support a role of PD- 1-PD-L1 blockade in improving the effectiveness of CAR T-cell therapy.\n\nThe objectives of this phase I\u002FII study is to determine the safety, efficacy and feasibility of Nivolumab (Opdivo®)- an anti-PD1 treatment- combined to tisagenlecleucel in a cohort of relapsed or refractory B-ALL patients, aged 1-25 years old, previously treated by tisagenlecleucel (Kymriah®), with a demonstrated early loss of B-cell aplasia (within 6 months), a surrogate marker of the loss of CAR T-cells or their non- functionality.\n\nMore specifically, the main objectives are:\n\n• In cohort 1 that includes patients with a MRD negative disease status combined to an early loss (within 6 months) of B-cell aplasia :\n\nTo determine the optimal starting time of Nivolumab (Opdivo®) in terms of safety and efficacy among 4 candidate time points (day 14, day 11, day 5, and day - 1).\n\n• In cohort 2 that includes relapsed patients with an early loss (within 6 months) of B-cell aplasia :\n\nTo estimate the feasibility in terms of safety and efficacy of a very early start of nivolumab (day-1), prior to the reinfusion of tisagenlecleucel",[26,363],"Acute Lymphoblastic Leukemia, in Relapse","2024-05-26",{"date":366,"type":31},"2024-05-29",{"date":368,"type":31},"2023-03-15",{"date":370,"type":19},"2027-03",{"name":372,"class":92},"Assistance Publique - Hôpitaux de Paris",13,""]