[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pcnsl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pcnsl":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100619917","phase-2-a-multicenter-prospective-clinical-trial-with-a-concurrent-control-evaluating-methotrexate-combined-with-rituximabsintilimab-and-pirtobrutinib-vs-investigator-selected-standard-of-care-in-treatment-naive-pcnsl-100619917",false,"NCT07350850","A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL","In Treatment-Naive Patients With Primary Central Nervous System Lymphoma (PCNSL): A Multicenter, Prospective, Concurrent-Control Study of Methotrexate, , Rituximab,, Sintilimab ,Pirtobrutinib Versus Investigator-Selected Standard of Care","PRIME-PCNSL","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Voluntarily signed informed consent.\n3. ECOG Performance Status 0-3.\n4. Expected survival \\> 3 months.\n5. Histopathologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) restricted to the CNS or eyes (PCNSL).\n6. Measurable lesion on contrast-enhanced MRI (\\>10x10 mm) or positive CSF cytology for leptomeningeal disease.\n7. No prior systemic treatment for lymphoma (corticosteroids excepted).\n8. Adequate bone marrow and organ function (ANC \\>=1.5x10\\^9\u002FL, PLT \\>=80x10\\^9\u002FL, Hb \\>=80 g\u002FL; Bilirubin \\\u003C=1.5xULN, AST\u002FALT \\\u003C=2.5xULN; Creatinine \\\u003C=1.5xULN or CrCl \\>=60 mL\u002Fmin) .\n9. Stable controlled comorbidities allowed (e.g., hypertension with blood pressure \\\u003C=160\u002F100 mmHg, type 2 diabetes with HbA1c \\\u003C=8%, mild coronary heart disease without myocardial infarction in the past 6 months).\n10. Basic communication ability to complete PROs questionnaires (no severe cognitive impairment).\n11. Reproductive-aged females and males with childbearing potential: No pregnancy plans during the study and 3 months after treatment discontinuation; use effective contraception (abstinence, physical contraception, or hormonal contraceptives initiated \\>=3 months before first dose). Males prohibited from donating sperm during treatment and 3 months after discontinuation.\n12. For Observational Cohort (Palliative Care Subgroup only): Pathologically confirmed DLBCL restricted to the CNS or eyes; Follow-up available for efficacy assessment (at least one CR evaluation) .\n\nExclusion Criteria:\n\n1.Prior treatment with PD-1\u002FPD-L1 inhibitors or CTLA4 monoclonal antibodies. Uncontrolled active infection. 2.Uncontrolled or significant cardiovascular diseases: 3.Congestive heart failure (NYHA class III\u002FIV),\n\n1. myocardial infarction, unstable angina within 6 months before first dose; arrhythmia requiring treatment; LVEF \\\u003C50%.\n2. Primary cardiomyopathy.\n3. History of clinically significant QTc prolongation, second-degree type II\u002Fthird-degree atrioventricular block, or QTc interval (Fridericia method) \\>470 msec (females) \u002F \\>480 msec (males).\n4. Atrial fibrillation (EHRA grade ≥2b).\n5. Refractory hypertension. 4.Active hepatitis B\u002FC infection (HBV-DNA ≥ detection limit, HCV RNA positive) or syphilis. (Exceptions: HBV-DNA \\\u003C detection limit, cured HCV).\n\n5.HIV infection. 6.Prior organ transplantation or allogeneic stem cell transplantation. 7.Pregnant or lactating females. 8.Prior\u002Fcurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis (unsuitable for study per investigator).\n\n9.Autoimmune diseases requiring systemic treatment within 2 years. 10.For Observational Cohort (Palliative Care Subgroup only): Incomplete clinical data (e.g., no pathological report, inability to perform MRI\u002FPET-CT assessment).","ALL","18 Years",{"count":20,"type":21},77,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of a four-drug combination regimen as first-line treatment for adults aged 18 years and older with newly diagnosed primary central nervous system lymphoma (PCNSL). The main questions it aims to answer are:\n\nDoes the combination of pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate achieve a higher complete response rate than standard treatment for newly diagnosed PCNSL? What is the safety and tolerability profile of this four-drug combination regimen? Researchers will compare the experimental four-drug combination to investigator-selected standard-of-care regimens (all based on high-dose methotrexate) to see if the experimental regimen improves complete response rate, progression-free survival, and overall survival while maintaining an acceptable safety profile.\n\nParticipants will:\n\nBe assigned to either the experimental group or the standard treatment group based on their personal preference Receive 6 cycles of induction therapy (21 days per cycle) with their assigned treatment regimen Undergo regular clinical assessments, including contrast-enhanced brain MRI scans, blood tests, and cerebrospinal fluid examinations Complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, mid-treatment, end of treatment, and follow-up visits Receive optional consolidation or maintenance therapy based on their response to induction treatment Be followed for up to 2 years after completing treatment to monitor for disease progression and long-term outcomes",[27,28],"PCNSL","Primary Central Nervous System Lymphoma",[30,31,32,33,34,35],"Primary Central Nervous System Lymphoma (PCNSL)","Methotrexate","Rituximab","Sintilimab","Pirtobrutinib","Real-World Evidence","RECRUITING","2026-05-30",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":40},"2025-12-25",{"date":44,"type":21},"2029-06-30",{"name":46,"class":47},"Tongji Hospital","OTHER",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100558702","phase-1-a-study-of-pomadomide-in-combination-with-rituximab-and-methotrexate-for-newly-diagnosed-primary-central-nervous-system-lymphoma-100558702","NCT06554561","A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma","The Safety and Efficacy of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma : A Prospective, Multicenter, Phase I\u002FII Study","Inclusion Criteria:\n\n* Histopathologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).\n* The lesions were confined to the central nervous system, including the brain, spinal cord, eyes and meninges.\n* Through physical examination, imaging examination (including CT, MRI, PET-CT, etc.) and bone marrow puncture examination, it was confirmed that no parts other than the central nervous system were involved.\n* Patients who have not previously received chemotherapy or radiotherapy (except those with dexamethasone less than 10mg\u002F day (or equivalent dose) and duration less than 5 days).\n* Aged between 18 and 75 (inclusive).\n* Eastern Cooperative Oncology Group performance status 0 to 3.\n* Measurable disease was defined as at least ≥1.0cm in short-diameter by enhanced MRI.\n* Life expectancy of ≥ 3 months (in the opinion of the investigator).\n* Participants must be able to understand and be willing to sign a written informed consent document.\n* Participants can follow up on schedule, communicate well with the investigator and complete the trial according to the trial regulations.\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\nExclusion Criteria:\n\n* Have systemic lymphoma disease.\n* Previous systemic or local treatment such as chemotherapy and\u002For radiotherapy and\u002For hematopoietic stem cell transplantation.\n* Previous or concurrent history of other malignant tumors requiring active therapy.\n* Chronic or currently active infectious diseases requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV infections).\n* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, bleeding diseases, thrombotic diseases, connective tissue diseases and other diseases.\n* Patients with other uncontrolled diseases that the researchers deemed unsuitable for inclusion.\n* Laboratory test values at screening (unless due to lymphoma) : White blood cell count \\\u003C 3.5×109\u002FL, neutrophils \\\u003C1.5×109\u002FL, platelets \\\u003C80×109\u002FL, hemoglobin \\\u003C100g\u002FL, ALT or AST 2.5 times higher than the upper limit of normal, bilirubin 1.5 times higher than the upper limit of normal, creatinine level 1.5 times higher than the upper limit of normal.\n* Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV. HbsAg positive patients need to check HBV-DNA \\\u003C 10\\^4 to be enrolled. In addition, if HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV-DNA testing is also required, and HBV-DNA results \\\u003C 10\\^4 are required to be enrolled and continue treatment and monitoring of HBV-DNA. HCV antibody positive patients need to check HCV-RNA quantitative DNA \\\u003C 10\\^3 to be enrolled.\n* Pregnant or lactating women.\n* Those with a history of drug use or abuse were asked.\n* Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol.\n* Known allergy to the investigational drug or its related ingredients.\n* Patients are unable to swallow capsules or suffer from diseases or conditions that severely affect gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, or complete intestinal obstruction.\n* Patients who cannot withstand enhanced MRI.\n* Participants considered unsuitable for this clinical trial due to various other reasons.","75 Years",{"count":58,"type":21},43,[60,24],"PHASE1","This is a prospective, multicenter, single-arm, open Phase Ib\u002FII clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg\u002Fd, 4mg\u002Fd and 5mg\u002Fd. In strict accordance with the \"3+3\" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion\u002Fexclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.",[27],[27,64,32,31],"Pomadomide","2024-08-13",{"date":67,"type":40},"2024-08-15",{"date":69,"type":21},"2024-08-31",{"date":71,"type":21},"2029-08-31",{"name":73,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1]