[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651765":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":48,"responsibleParty":96,"collaborators":28,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":28,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":125,"whyStopped":28,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"R-MA-PD-1 (Experimental)","EXPERIMENTAL","Rituximab 375 mg\u002Fm2 (D0), methotrexate 3.5 g\u002Fm2 (D1), cytarabine (D2-3 or D2 by age\u002FECOG), plus penpulimab 200 mg (D5), every 21 days for 6 induction cycles, followed by response- and age-adapted consolidation and penpulimab maintenance.",[13,14,15,16],"Biological: Penpulimab","Drug: Rituximab","Drug: Methotrexate","Drug: Cytarabine",{"label":18,"type":19,"description":20,"interventionNames":21},"R-MA (Active Comparator)","ACTIVE_COMPARATOR","Rituximab 375 mg\u002Fm2 (D0), methotrexate 3.5 g\u002Fm2 (D1), and cytarabine (D2-3 or D2 by age\u002FECOG), every 21 days for 6 induction cycles, followed by response- and age-adapted consolidation (ASCT or WBRT).",[14,15,16],[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Penpulimab","Anti-PD-1 monoclonal antibody, 200 mg intravenously on Day 5 of each induction cycle; continued as maintenance in responders.",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Rituximab","375 mg\u002Fm2 intravenously on Day 0 of each induction cycle.",[18,9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Methotrexate","3.5 g\u002Fm2 intravenously on Day 1 of each induction cycle.",[18,9],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Cytarabine","Age \\\u003C60 or ECOG ≤2: 2 g\u002Fm2 q12h on Days 2-3; age ≥60 or ECOG \\>2: 1 g\u002Fm2 q12h on Day 2 (from cycle 2).",[18,9],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Wei Xu","CONTACT","+86 13951699449","xuwei10000@hotmail.com",[49,61,69,80,88],{"facility":50,"status":28,"city":51,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":28},"The First People's Hospital of Changzhou","Changzhou","Jiangsu","China","CN",{"type":56,"coordinates":57},"Point",[58,59],119.95401,31.77359,{"lat":59,"lon":58},{"facility":62,"status":28,"city":63,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":64,"geoPoint":68,"contacts":28},"The First People's Hospital of Huai'an","Huai'an",{"type":56,"coordinates":65},[66,67],119.01917,33.58861,{"lat":67,"lon":66},{"facility":70,"status":28,"city":71,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The First Affiliated Hospital of Nanjing Medical University","Nanjing",{"type":56,"coordinates":73},[74,75],118.77778,32.06167,{"lat":75,"lon":74},[78],{"name":44,"role":79,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"facility":81,"status":28,"city":82,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":83,"geoPoint":87,"contacts":28},"Wuxi People's Hospital","Wuxi",{"type":56,"coordinates":84},[85,86],120.28857,31.56887,{"lat":86,"lon":85},{"facility":89,"status":28,"city":90,"state":52,"zip":28,"country":53,"countryCode":54,"cosmosGeoPoint":91,"geoPoint":95,"contacts":28},"Yixing People's Hospital","Yixing",{"type":56,"coordinates":92},[93,94],119.82016,31.36059,{"lat":94,"lon":93},{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","WEI XU","Chief Physician, Department of Hematology","100651765","r-ma-pd-1-versus-r-ma-in-treatment-naive-primary-cns-lymphoma-100651765",false,"NCT07764601","R-MA-PD-1 Versus R-MA in Treatment-naive Primary CNS Lymphoma","A Prospective, Open-label, Randomized Controlled Study Comparing Rituximab, Methotrexate, Cytarabine, and Penpulimab (R-MA-PD-1) Versus Rituximab, Methotrexate, and Cytarabine (R-MA) in Treatment-naive Patients With Primary Central Nervous System Lymphoma","RM-MA-PD1","Inclusion Criteria:\n\n1. Fully understands the study and voluntarily signs informed consent.\n2. Age 18 to 80 years.\n3. Treatment-naive, pathologically (immunophenotypically) confirmed PCNSL (per 2016 WHO classification).\n4. Diffuse large B-cell lymphoma originating in the CNS without other organ involvement, confirmed by PET-CT or contrast-enhanced CT.\n5. Expected survival more than 3 months.\n6. Laboratory: creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault); INR ≤1.5 x ULN or aPTT ≤1.5 x ULN (INR 2-3 allowed if on warfarin); LVEF ≥50%.\n7. GFR ≥60 mL\u002Fmin.\n8. Participants of childbearing potential must agree to use effective contraception during the study and for 30 days after the last dose.\n\nExclusion Criteria:\n\n1. Contraindication to any study drug.\n2. Clinically significant liver disease, including viral or other hepatitis or cirrhosis (active HBV or active hepatitis C as defined).\n3. HIV infection.\n4. History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of penpulimab.\n5. Prior anti-PD-1\u002FPD-L1\u002FPD-L2, anti-CTLA-4 antibody, CAR-T, or any other agent targeting T-cell co-stimulation or checkpoint pathways.\n6. Congestive heart failure (NYHA \\>2); acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months.\n7. Congenital long QT syndrome or QTcF \\>480 ms.\n8. Other malignancy within the past 5 years (except adequately treated in situ cervical carcinoma, basal cell skin carcinoma, in situ breast carcinoma, or a second primary cancer cured and recurrence-free for 5 years).\n9. Pregnant or lactating women, or intending to become pregnant during the study.\n10. History of clinically significant neurological or psychiatric disorder, or substance\u002Fdrug abuse.\n11. Clinically significant active infection.","ALL","18 Years","80 Years",{"count":112,"type":113},58,"ESTIMATED","INTERVENTIONAL",[116],"NA","This is a prospective, open-label, multicenter, randomized controlled study in treatment-naive patients with primary central nervous system lymphoma (PCNSL, DLBCL type). Eligible participants are randomized 1:1 to the experimental arm (R-MA-PD-1: rituximab, methotrexate, cytarabine plus penpulimab) or the control arm (R-MA: rituximab, methotrexate, cytarabine). Induction is administered every 21 days for 6 cycles, followed by risk- and response-adapted consolidation (ASCT or whole-brain radiotherapy) and penpulimab maintenance. The primary objective is to compare the 2-year progression-free survival rate between the two arms.",[119,120],"Primary Central Nervous System Lymphoma","Diffuse Large B-Cell Lymphoma",[122,25,123,124,31],"PCNSL","PD-1 inhibitor","High-dose methotrexate","NOT_YET_RECRUITING","2026-08-12",{"date":128,"type":129},"2026-08-14","ACTUAL",{"date":131,"type":113},"2026-08",{"date":133,"type":113},"2029-08",{"name":98,"class":6},5]