[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640426":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":48,"collaborators":19,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":19,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":19,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"R-PMDT","EXPERIMENTAL","Eligible patients will receive six cycles of the R-PMDT regimen.",[13],"Drug: R-PMDT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Rituximab (375 mg\u002Fm², IV infusion) is given on day 0; methotrexate (3.5 g\u002Fm², IV infusion over 3 hours) on day 1; dexamethasone (20 mg, IV infusion) on days 1-4; thiotepa (30 mg\u002Fm², IV infusion) on day 1; and pirtobrutinib (200 mg, oral) on days 4-21 or until the day prior to methotrexate administration in the next cycle.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Wei Liu, Docter","CONTACT","86-022-23608461","liuwei@ihcams.ac.cn",{"name":27,"role":23,"phone":19,"phoneExt":28,"email":19},"Dehui Zou, Docter","8602223608461",[30],{"facility":31,"status":32,"city":33,"state":19,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Institute of Hematology & Blood Diseases Hospital","RECRUITING","Tianjin","022","China","CN",{"type":38,"coordinates":39},"Point",[40,41],117.17667,39.14222,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":19,"email":47},"Shuo Chen","022-23909095","ec@ihcams.ac.cn",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Zou Dehui","Director of Lymphoma Center Transplantation and Cellular Therapy Unit","100640426","phase-2-r-pmdt-regimen-in-newly-diagnosed-pcnsl-100640426",false,"NCT07604987","R-PMDT Regimen in Newly Diagnosed PCNSL","A Prospective, Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Newly diagnosed primary central nervous system diffuse large B-cell lymphoma\n* Adequate hematologic function: ANC ≥1.0×10⁹\u002FL, PLT ≥75×10⁹\u002FL\n* Adequate hepatic function: ALT\u002FAST ≤3×ULN; total bilirubin ≤1.5×ULN\n* Adequate renal function: serum creatinine ≤2×ULN or CrCl ≥40 mL\u002Fmin\n* LVEF ≥55% by echocardiography\n* Baseline oxygen saturation \\>92% on room air\n* Expected survival ≥3 months\n\nExclusion Criteria:\n\n* Prior anti-lymphoma therapy other than corticosteroids.\n* Uncontrolled significant cardiovascular or cerebrovascular disease.\n* Uncontrolled active systemic bacterial, fungal, or viral infection.\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive). Patients with positive hepatitis B surface antigen and\u002For core antibody but HBV-DNA \\\u003C 1000 IU\u002FmL may be included and should receive concurrent oral antiviral prophylaxis against HBV reactivation.\n* Hypersensitivity to any study drug or its components.\n* Other active malignancy, except for adequately controlled non-melanoma skin cancer, in situ carcinoma, or malignancy that has been in complete remission for ≥5 years.\n* Pregnant or lactating women. Fertile patients unwilling to use effective contraception.\n* Other conditions deemed inappropriate by the investigator.","ALL","18 Years",{"count":62,"type":63},33,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","A total of six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa) will be administered to patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluating the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.",[69],"Primary Central Nervous System (CNS) Lymphoma",[9,71],"PCNSL","2026-05-17",{"date":74,"type":75},"2026-05-22","ACTUAL",{"date":77,"type":63},"2026-05-20",{"date":79,"type":63},"2030-05-20",{"name":50,"class":6},1]