[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645142":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":88,"centralContacts":89,"locations":95,"responsibleParty":111,"collaborators":88,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":88,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":88,"enrollmentInfo":124,"targetDuration":88,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":138,"whyStopped":88,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Orelabrutinib Combined with chemotherapy followed by monotherapy in ND MCD subtype DLBCL","EXPERIMENTAL","For MCD subtype DLBCL (including IP-LBCLs) that have undergone two cycles of induction therapy, combine orelabrutinib treatment starting from the third cycle.\n\nFor patients with poor prognostic factors (meeting one of the following: Ann Arbor stage III\u002FIV; IPI score 3-5; aaIPI score 2-3; high-intermediate or high-risk group per MSKCC and\u002For IELSG criteria), continue with two additional cycles of orelabrutinib-combined induction therapy, followed by orelabrutinib monotherapy maintenance for 2 years or until disease progression or intolerable toxicity.\n\nFor patients without poor prognostic factors, administer orelabrutinib monotherapy maintenance for 1 year or until disease progression or intolerable toxicity.",[13,14,15,16,17,18,19,20,21,22],"Drug: R-CHOP+Orelabrutinib","Drug: POLA-R-CHP+orelabrutinib","Drug: R-miniCHOP +orelabrutinib","Drug: Zuberitamab-CHOP+orelabrutinib","Drug: POLA-Hi-CHP+orelabrutinib","Drug: Hi-miniCHOP +orelabrutinib","Drug: RMTO","Drug: HiMTO","Drug: Pola-R-miniCHP+O","Drug: Pola-Hi-miniCHP",[24,36,43,48,54,59,65,72,77,83],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","R-CHOP+Orelabrutinib","R-CHOP Regimen Rituximab: 375 mg\u002Fm², Day 0 Cyclophosphamide: 750 mg\u002Fm², Day 1 Doxorubicin: 50 mg\u002Fm², Day 1 Vincristine: 1.4 mg\u002Fm², Day 1 (maximum single dose: 2 mg) Prednisone: 100 mg, Days 1-5 Orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[30,31,32,33,34,35],"Rituximab","Cyclophosphamide","Doxorubicin","Vincristine","Prednisone","Orelabrutinib",{"type":25,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"POLA-R-CHP+orelabrutinib","POLA-R-CHP+orelabrutinib Rituximab: 375 mg\u002Fm², Day 1 Vepoliximab: 1.8 mg\u002Fkg, Day 1 Cyclophosphamide: 750 mg\u002Fm², Day 1 Doxorubicin: 50 mg\u002Fm², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[30,41,31,32,34,42],"Vepoliximab","orelabrutinib",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"R-miniCHOP +orelabrutinib","R-miniCHOP Regimen Rituximab: 375 mg\u002Fm², Day 0 Cyclophosphamide: 400 mg\u002Fm², Day 1 Doxorubicin: 25 mg\u002Fm², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg\u002Fm², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[30,31,32,33,34,42],{"type":25,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Zuberitamab-CHOP+orelabrutinib","Zuberitamab: 375 mg\u002Fm², Day 0 Cyclophosphamide: 400 mg\u002Fm², Day 1 Doxorubicin: 25 mg\u002Fm², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg\u002Fm², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[53,31,32,33,34],"Zuberitamab",{"type":25,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"POLA-Hi-CHP+orelabrutinib","POLA-Hi-CHP+orelabrutinib Zuberitamab: 375 mg\u002Fm², Day 1 Vepoliximab: 1.8 mg\u002Fkg, Day 1 Cyclophosphamide: 750 mg\u002Fm², Day 1 Doxorubicin: 50 mg\u002Fm², Day 1 Prednisone: 100 mg, Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[41,31,32,34,42,53],{"type":25,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Hi-miniCHOP +orelabrutinib","Hi-miniCHOP Regimen Zuberitamab: 375 mg\u002Fm², Day 0 Cyclophosphamide: 400 mg\u002Fm², Day 1 Doxorubicin: 25 mg\u002Fm², Day 1 Vincristine: 1 mg, Day 1 Prednisone: 40 mg\u002Fm², Days 1-5 orelabrutinib 150mg QD every 21 days per cycle in Induction therapy, 28 days\u002Fcycle during maintenance therapy",[9],[53,31,32,33,64,42],"Prednisone,",{"type":25,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"RMTO","RMTO Regimen Rituximab: 375 mg\u002Fm², Day 1 Methotrexate: 3.5 g\u002Fm², Day 2 Thiotepa 30 mg\u002Fm² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days\u002Fcycle",[9],[30,42,70,71],"Thiotepa","Methotrexate",{"type":25,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"HiMTO","HiMTO Regimen Zuberitamab: 375 mg\u002Fm², Day 1 Methotrexate: 3.5 g\u002Fm², Day 2 Thiotepa 30 mg\u002Fm² Day 4 Orelabrutinib: 150 mg, Days 1-21 every 21 days per cycle in Induction therapy, maintenance therapy 28 days\u002Fcycle",[9],[53,42,70,71],{"type":25,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Pola-R-miniCHP+O","Pola-R-miniCHP Regimen Polatuzumab vedotin: 1.8 mg\u002Fkg IV, Day 1 Rituximab: 375 mg\u002Fm² IV, Day 1 Cyclophosphamide: 400 mg\u002Fm² IV, Day 1 Doxorubicin: 25 mg\u002Fm² IV, Day 1 Prednisone: 40 mg\u002Fm² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days\u002Fcycle",[9],[82,30,31,32,34],"Polatuzumab vedotin",{"type":25,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Pola-Hi-miniCHP","Pola-Hi-miniCHP Regimen (21-day cycle, up to 6 cycles) Polatuzumab vedotin: 1.8 mg\u002Fkg IV, Day 1 Zuberitamab: 375 mg\u002Fm² IV, Day 1 Cyclophosphamide: 400 mg\u002Fm² IV, Day 1 Doxorubicin: 25 mg\u002Fm² IV, Day 1 Prednisone: 40 mg\u002Fm² PO, Days 1-5 every 21 days per cycle in Induction therapy, maintenance therapy 28 days\u002Fcycle",[9],[82,31,32,34,53,42],null,[90],{"name":91,"role":92,"phone":93,"phoneExt":88,"email":94},"ou bai, MD\u002FPHD","CONTACT","13039046656","oubai16@163.com",[96],{"facility":97,"status":88,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"The First Bethune Hospital of Jilin University","Changchun","Jilin","130021","China","CN",{"type":104,"coordinates":105},"Point",[106,107],125.32278,43.88,{"lat":107,"lon":106},[110],{"name":91,"role":92,"phone":93,"phoneExt":88,"email":94},{"type":112,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"SPONSOR_INVESTIGATOR","Ou Bai, MD\u002FPHD","Principal Investigator, Professor","100645142","phase-2-orelabrutinib-combined-with-induction-therapy-followed-by-sequential-monotherapy-maintenance-in-mcd-subtype-diffuse-large-b-cell-lymphoma-100645142",false,"NCT07677813","Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma","Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study","Inclusion Criteria:\n\n* Patients of any gender, aged ≥18 years;\n* Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);\n* No prior treatment history;\n* Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml\u002Fmin;\n* Bilirubin \\\u003C1.5 times the upper limit of normal;\n* Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;\n* Patients with a history of stroke or bleeding within the past 6 months;\n* Patients requiring treatment with strong CYP3A inhibitors;\n* Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;\n* Patients with a history of organ transplantation;\n* Patients with a history of or concurrent other malignant tumors.","ALL","18 Years",{"count":125,"type":126},66,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.",[132],"DLBCL - Diffuse Large B Cell Lymphoma",[42,134,135,136,137],"DLBCL","chemotherapy","Maintenance therapy","MCD subtype","NOT_YET_RECRUITING","2026-06-25",{"date":141,"type":142},"2026-07-01","ACTUAL",{"date":144,"type":126},"2026-06-16",{"date":146,"type":126},"2031-12-31",{"name":113,"class":6},1]