[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558828":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":38,"armGroups":42,"interventions":50,"overallOfficials":38,"centralContacts":64,"locations":74,"responsibleParty":85,"collaborators":38,"id":87,"slug":38,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":38,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":38,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":38,"overallStatus":77,"whyStopped":38,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Recommended phase 2 dose","To determine the recommended phase 2 dose for Selinexor.","Up to 21days",{"measure":14,"description":15,"timeFrame":16},"Objective response rate (ORR) for Phase II study","The objective response rate (ORR) is defined as the proportion of patients with CR or PR at the end of induction treatment.","18 weeks",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"Progression-free survival (PFS)","PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.","Up to 2 years after enrollment",{"measure":23,"description":24,"timeFrame":21},"Overall survival (OS)","OS is defined as the duration of time from start of treatment to time of death.",{"measure":26,"description":27,"timeFrame":21},"Duration of response","The duration of overall response is measured from the time achieving ORR to time of progression, relapse or death, whichever occurs first.",[29,32],{"measure":30,"description":31,"timeFrame":21},"ctDNA mutation and mean ctDNA concentration in serum and cerebrospinal fluid","Types of ctDNA mutations and frequency are measured by next generation sequencing. The mean ctDNA concentration is the concentration of ctDNA expressed as mean tumor molecules \u002Fml at specific time points.",{"measure":33,"description":34,"timeFrame":21},"The levels of cytokine concentration in serum and cerebrospinal fluid","The levels of cytokine will be analyzed by ELISA in all patients recruited at Baseline and specific time point. The cytokine profile includes IL-6, IL-10, TNF-α, IFN-γ, IL-2 and IL-4",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":38,"timePerspective":38,"maskingInfo":40},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":41,"maskingDescription":38,"whoMasked":38},"NONE",[43],{"label":44,"type":45,"description":38,"interventionNames":46},"selinexor-based treatment","EXPERIMENTAL",[47,48,49],"Drug: Selinexor","Drug: Temozolomide","Drug: Anti-PD-1 monoclonal antibody",[51,56,60],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":38},"DRUG","Selinexor","Selinexor dose escalation: 40,60,80mg respectively every week, and dose expansion at the RP2D of Selinexor,every 3 weeks for 6 cycles.",[44],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":38},"Temozolomide","Temozolomide 150mg\u002Fm2 po d1-5 every 3 weeks for 6 cycles.",[44],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":38},"Anti-PD-1 monoclonal antibody","The dose of anti-PD-1 monoclonal antibody is fixed dose 200 mg intravenously every 3 weeks until until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).",[44],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":38,"email":69},"Xianggui Yuan","CONTACT","+8613989883884","yuanxg@zju.edu.cn",{"name":71,"role":67,"phone":72,"phoneExt":38,"email":73},"Wenbin Qian","+8613605801032","qianwb@zju.edu.cn",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":38,"geoPoint":38,"contacts":83},"2nd Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hanzhou","Zhejiang","310009","China","CN",[84],{"name":71,"role":67,"phone":72,"phoneExt":38,"email":73},{"type":86,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100558828",false,"NCT06556199","A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","The Efficiency and Safety of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma: A Prospective, Single-arm, Open, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Aged between 18 and 75 (inclusive).\n* Participants must be able to understand and be willing to sign a written informed consent document.\n* Eastern Cooperative Oncology Group performance status 0 to 3.\n* Life expectancy of ≥ 3 months (in the opinion of the investigator).\n* Primary central nervous system lymphoma (PCNSL) of B-cell origin confirmed by pathology (histology or cytology)\n* Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.\n* Recurrent\u002Frefractory PCNSL: Must have received at least one systemic treatment with methotrexate-based treatment.\n* Any non-hematological toxicity associated with previous treatment should return to grade 1 or normal (except hair loss according to NCI CTCAE version 5.0)\n* Bone marrow and organ function meet the following criteria (no blood transfusion within 14 days prior to screening, no G-CSF, no medication correction) :\n\n  1. Bone marrow function: absolute value of neutrophils ≥1.5×10\\^9\u002FL, platelets ≥80×10\\^9\u002FL, hemoglobin ≥80 g\u002FL;\n  2. Liver function: serum total bilirubin ≤1.5×ULN (≤3.0×ULN, if there is liver metastasis); Glutamic oxalic aminotransferase (AST) and glutamic pyruvic aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN, if there is liver metastasis);\n  3. Coagulation function: International standardized ratio (INR) and activated partial thrombin time ≤1.5×ULN;\n  4. Renal function: serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin (male: Cr (ml\u002Fmin) = (140-age) × body weight (kg) \u002F72× serum creatinine concentration (mg\u002Fdl); Female: Cr (ml\u002Fmin) = (140- age) × body weight (kg) \u002F85× serum creatinine concentration (mg\u002Fdl)\n* Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.\n* Can accept multiple MRI\u002FCT and lumbar puncture examination.\n* Swallowing oral tablets\u002Fcapsules without difficulty.\n* Good compliance, willing to follow the visit schedule, dosing schedule, laboratory examination and other test procedure.\n\nExclusion Criteria:\n\n* Pathological diagnosis was T cell lymphoma.\n* Anti-tumor therapy with chemotherapy, radiotherapy, immunotherapy or antibody drugs, or Chinese herbal medicine with anti-tumor indications, small-molecule targeted therapy within 2 weeks, monoclonal antibody-coupled drugs or cytotoxin therapy within 10 weeks, and autologous stem cell transplantation within 6 months before the first administration.\n* Participation in another clinical study with an investigational product during the 4 weeks prior to the first day of study treatment.\n* Patients who use systemic adrenal corticosteroids for more than 5 days within 14 days prior to medication or who need to take \\>10mg of dexamethasone or equivalent drugs daily to control CNS disease.\n* Active concurrent malignancy requiring active therapy.\n* Prior treatment with temozolomide or anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs within 6 months prior to initial administration\n* Have uncontrolled or significant cardiovascular disease, including (but not limited to) : Any of the following: congestive heart failure (NYHA Class III or IV);myocardial infarction; unstable angina; or the presence of an arrhythmia requiring treatment at the time of screening with a left ventricular ejection fraction (LVEF) \\\u003C 50% in the 6 months prior to initial dosing; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy); A clinically significant history of prolonged QTc, grade II type II atrioventricular block or grade III atrioventricular block, or QTc interphase (method F) \\> 470 msec (female) or \\> 480msec (male);Atrial fibrillation (EHRA grade ≥2b);Patients with unmanageable hypertension were deemed unsuitable for participation in the study.\n* Uncontrolled infections or infections that require intravenous antibiotic treatment.\n* Chronic hepatitis B carriers with active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA≥ the detection limit of each center; Hepatitis C: HCV RNA positive) or syphilis. Notes: Non-active HBV surface antigen (HBsAg) carriers, subjects with active HBV infection and persistent anti-HBV inhibition (HBV DNA \\\u003C each center detection limit), and subjects cured of HCV can be enrolled.\n* Human immunodeficiency virus (HIV) infection\n* Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery.\n* Prior allogenic stem cell transplant.\n* For female subjects, they are currently pregnant or breastfeeding.\n* Allergy to the investigational drug or excipient.\n* The patient has active mental illness, alcohol, drug or substance abuse.\n* The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the patient's safety or compliance with the study procedure.\n* There are other conditions that the investigator considers inappropriate to participate in this clinical trial.","ALL","18 Years","75 Years",{"count":97,"type":98},38,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","This study is a prospective, single-arm, open label, Phase Ib\u002FII clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed\u002Frefractory primary central nervous system lymphoma(PCNSL). Phase Ib used a \"3+3\" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).",[105],"Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","2025-07-28",{"date":108,"type":109},"2025-07-31","ACTUAL",{"date":111,"type":109},"2024-08-31",{"date":113,"type":98},"2028-08-31",{"name":5,"class":6},1]