[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624926":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":22,"responsibleParty":37,"collaborators":22,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":22,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":22,"enrollmentInfo":50,"targetDuration":22,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":22,"overallStatus":60,"whyStopped":22,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":22},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Polatuzumab Vedotin in Combination With Rituximab and Chidamide","EXPERIMENTAL","Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.",[13,14,15],"Drug: Polatuzumab Vedotin","Drug: Rituximab (R)","Drug: Chidamide",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Polatuzumab Vedotin","1.8 mg\u002Fkg intravenously on Day 1 of each 21-day cycle.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Rituximab (R)","375 mg\u002Fm² intravenously once weekly during Cycle 1, followed by administration on Day 1 of each subsequent cycle.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Chidamide","20 mg, po, biw",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Qingqing Cai, MD. PhD.","CONTACT","+8602087342823","caiqq@sysucc.org.cn",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Qingqing Cai","Principal Investigator","100624926","phase-1-phase-ibii-study-of-polatuzumab-vedotin-in-combination-with-rituximab-and-chidamide-in-newly-diagnosed-elderly-patients-with-double-expressor-dlbcl-100624926",false,"NCT07415980","Phase Ib\u002FII Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide in Newly Diagnosed Elderly Patients With Double-Expressor DLBCL","A Multicenter, Phase Ib\u002FII Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;\n* Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).\n* Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC\u002FBCL2 double expression, and no double-hit or triple-hit lymphoma.\n* At least one measurable or evaluable lesion according to the Lugano 2014 criteria.\n* No prior systemic therapy for DLBCL.\n* Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* Other subtypes of DLBCL.\n* Lymphoma involvement in the central nervous system or meninges.\n* Active infections.\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n* Patients with mental disorders or those unable to provide informed consent\n* Any other condition deemed by the investigator to be unsuitable for study enrollment.\n* Known hypersensitivity to any investigational drug.","ALL","60 Years",{"count":51,"type":52},68,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","This is a single-arm, prospective, multicenter, open-label phase Ib\u002FII study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC\u002FBCL2 double-expressor diffuse large B-cell lymphoma.",[59],"Double Expressor DLBCL","NOT_YET_RECRUITING","2026-02-10",{"date":63,"type":64},"2026-02-17","ACTUAL",{"date":66,"type":52},"2026-04-01",{"date":68,"type":52},"2031-04-01",{"name":5,"class":6}]