[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619917":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":96,"collaborators":100,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":26,"enrollmentInfo":119,"targetDuration":26,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Cohort","EXPERIMENTAL","Patients receive Rituximab, Methotrexate, Sintilimab, and Pirtobrutinib for 6 cycles (21 days\u002Fcycle).",[13],"Drug: Pirtobrutinib, Sintilimab, Rituximab, Methotrexate",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator Cohort","ACTIVE_COMPARATOR","Patients eligible for curative-intent therapy will receive one of the following three guideline-recommended, high-dose methotrexate (HD-MTX)-based first-line regimens, selected by the treating physician based on patient age, performance status, comorbidities, and clinical judgment:\n\nMATRix Regimen: Rituximab 375 mg\u002Fm² IV on Day 0; Methotrexate 3.5 g\u002Fm² IV on Day 1; Cytarabine 2 g\u002Fm² IV twice daily on Days 2-3; Thiotepa 30 mg\u002Fm² orally on Day 4. Cycle length: 21 days, up to 6 cycles.\n\nRMT Regimen: Rituximab 375 mg\u002Fm² IV on Day 0; Methotrexate 3.5 g\u002Fm² IV on Day 1; Temozolomide 150 mg\u002Fm² orally once daily on Days 1-5. Cycle length: 21 days, up to 6 cycles.\n\nMR-BTKi Regimen: Rituximab 375 mg\u002Fm² IV on Day 0; Methotrexate 3.5 g\u002Fm² IV on Day 1; Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21. Cycle length: 21 days, up to 6 cycles.",[19],"Drug: Standard of Care (Investigator Selected)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pirtobrutinib, Sintilimab, Rituximab, Methotrexate","Participants in this single-arm prospective cohort will receive the investigational combination therapy: Rituximab (375 mg\u002Fm\\^2, IV, Day 0), Methotrexate (3.5 g\u002Fm\\^2, IV, Day 1; adjusted to 1.0 g\u002Fm\\^2 for elderly\u002Ffrail patients), Sintilimab (200 mg, IV, Day 1), Pirtobrutinib (200 mg, PO, Days 1-21). Treatment cycles repeat every 21 days for up to 6 cycles.",[9],null,{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":26},"Standard of Care (Investigator Selected)",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Jia Wei, MD","CONTACT","027-83663200","jiawei@tjh.tjmu.edu.cn",[37,55,65,80],{"facility":38,"status":39,"city":40,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Fujian Medical University","RECRUITING","Xiamen","Fujian","China","CN",{"type":45,"coordinates":46},"Point",[47,48],118.08187,24.47979,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":26,"email":54},"Zhiyong Zeng","0591-87981022","zengzhiyong049@163.com",{"facility":56,"status":39,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":26},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000",{"type":45,"coordinates":61},[62,63],114.26667,30.58333,{"lat":63,"lon":62},{"facility":66,"status":39,"city":67,"state":68,"zip":69,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"China-Japan Union Hospital of Jilin University","Changchun","Jilin","130033",{"type":45,"coordinates":71},[72,73],125.32278,43.88,{"lat":73,"lon":72},[76],{"name":77,"role":33,"phone":78,"phoneExt":26,"email":79},"Lintao Bi","0431-84995222","bilt@jlu.edu.cn",{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":42,"countryCode":43,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Shanxi Provincial People's Hospital","NOT_YET_RECRUITING","Taiyuan","Shanxi","030012",{"type":45,"coordinates":87},[88,89],112.56028,37.86944,{"lat":89,"lon":88},[92],{"name":93,"role":33,"phone":94,"phoneExt":26,"email":95},"Jianxia He","0351-4960081","hejianxia125@163.com",{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jia Wei","chief physician",[101,103,105,107],{"name":81,"class":102},"OTHER_GOV",{"name":104,"class":6},"First Affiliated Hospital of Fujian Medical University",{"name":106,"class":6},"The General Hospital of Western Theater Command",{"name":108,"class":6},"China-Japan Union Hospital, Jilin University","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":120,"type":121},77,"ESTIMATED","INTERVENTIONAL",[124],"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",[127,128],"PCNSL","Primary Central Nervous System Lymphoma",[130,131,132,133,134,135],"Primary Central Nervous System Lymphoma (PCNSL)","Methotrexate","Rituximab","Sintilimab","Pirtobrutinib","Real-World Evidence","2026-05-30",{"date":138,"type":139},"2026-06-02","ACTUAL",{"date":141,"type":139},"2025-12-25",{"date":143,"type":121},"2029-06-30",{"name":5,"class":6},4]