[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-primary-central-nervous-system-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-primary-central-nervous-system-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100600941","phase-3-ignite-study-of-tirabrutinib-vs-rituximabtemozolomide-for-relapsedrefractory-primary-central-nervous-system-lymphoma-pcnsl-100600941",false,"NCT07104032","IGNITE: Study of Tirabrutinib vs Rituximab\u002FTemozolomide for Relapsed\u002FRefractory Primary Central Nervous System Lymphoma (PCNSL)","A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed\u002FRefractory Primary Central Nervous System Lymphoma","IGNITE","Inclusion Criteria\n\n1. Pathology report confirming the diagnosis of B-cell PCNSL\n2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:\n\n   * Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression.\n   * Refractory disease: Participants whose best response to the last treatment was stable disease or PD.\n3. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2\n5. Adequate bone marrow, renal, and hepatic function per central lab values\n6. Participants must agree to comply with all defined contraceptive requirements\n\nExclusion Criteria\n\n1. Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions\n2. Participants with non-B-cell PCNSL\n3. Participants with systemic presence of lymphoma\n4. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment\n5. Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:\n\n   * Equivalent of up to 10 milligram per day (mg\u002Fday) of prednisone for a disease other than PCNSL\n   * Equivalent of up to 50 mg\u002Fday of prednisone (equal to 8 mg\u002Fday dexamethasone) for participants with lesions of the brain and\u002For spinal cord\n6. Active malignancy, other than PCNSL requiring systemic therapy\n7. Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment\n8. Participants who are unable to swallow oral medication\n9. Prior Bruton's tyrosine kinase inhibitor treatment","ALL","18 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed\u002FRefractory Primary Central Nervous System Lymphoma (PCNSL).",[27],"Relapsed\u002FRefractory Primary Central Nervous System Lymphoma",[29],"Bruton's tyrosine kinase (BTK)","RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":34},"2026-06-12",{"date":38,"type":21},"2029-12",{"name":40,"class":41},"Ono Pharmaceutical Co., Ltd.","INDUSTRY",19,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100558828","phase-1-a-study-of-selinexor-in-combination-with-temozolomide-and-anti-pd-1-antibody-in-patients-with-relapsedrefractory-primary-central-nervous-system-lymphoma-100558828","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.","75 Years",{"count":52,"type":21},38,[54,55],"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).",[27],"2025-07-28",{"date":60,"type":34},"2025-07-31",{"date":62,"type":34},"2024-08-31",{"date":64,"type":21},"2028-08-31",{"name":66,"class":67},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1]