[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630859":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":63,"centralContacts":68,"locations":73,"responsibleParty":89,"collaborators":58,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":58,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":58,"enrollmentInfo":102,"targetDuration":58,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":75,"whyStopped":58,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chidamide group","EXPERIMENTAL","Chidamide Specification: 5mg \u002F tablet. Induction phase: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. 21 days\u002Fcycle. R-mini CHOP, Q3W.\n\nMaintenance phase: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab 375 mg\u002Fm² IV, once every 12 weeks. 21 days\u002Fcycle.",[13,14,15,16,17,18,19],"Drug: Chidamide","Drug: Rituximab","Drug: Cyclophosphamide","Drug: Doxorubicin","Drug: Vincristine","Drug: Prednisone","Drug: Chidamide + Rituximab maintenance",[21,30,36,42,48,54,59],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Chidamide","Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.",[9],[27,28,29],"CS055","HBI-8000","Tucidinostat",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Rituximab","Rituximab, 375 mg\u002Fm² IV, Cycle 1-4, Day 1.",[9],[35],"MabThera",{"type":22,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Cyclophosphamide","Cyclophosphamide, 400 mg\u002Fm² IV, Cycle 1-4, Day 2.",[9],[41],"Cytoxan",{"type":22,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Doxorubicin","Doxorubicin, 25 mg\u002Fm² IV, Cycle 1-4, Day 2.",[9],[47],"Hydroxydaunorubicin",{"type":22,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Vincristine","Vincristine, 1 mg\u002Fm² IV, Cycle 1-4, Day 2.",[9],[53],"VCR",{"type":22,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Prednisone","Prednisone, 40 mg\u002Fm² orally, Cycle 1-4, Days 1-5.",[9],null,{"type":22,"name":60,"description":61,"armGroupLabels":62,"otherNames":58},"Chidamide + Rituximab maintenance","Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg\u002Fm² IV, once every 12 weeks. 21 days\u002Fcycle.",[9],[64],{"name":65,"affiliation":66,"role":67},"Ou Bai, PHD","The First Bethune Hospital of Jilin University","PRINCIPAL_INVESTIGATOR",[69],{"name":65,"role":70,"phone":71,"phoneExt":58,"email":72},"CONTACT","13039046656","oubai16@163.com",[74],{"facility":66,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"RECRUITING","Changchun","Jilin","130021","China","CN",{"type":82,"coordinates":83},"Point",[84,85],125.32278,43.88,{"lat":85,"lon":84},[88],{"name":65,"role":70,"phone":71,"phoneExt":58,"email":72},{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"SPONSOR_INVESTIGATOR","Ou Bai, MD\u002FPHD","Director","100630859","phase-2-chidamide-combination-with-r-mini-chop-followed-by-chidamidecd20-maintenance-in-elderly-newly-diagnosed-mycbcl2-dlbcl-100630859",false,"NCT07493148","Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC\u002FBCL2+ DLBCL","A Phase II, Open-label, Single-arm Clinical Study of Chidamide in Combination With the R-mini CHOP Regimen, Followed by Chidamide Plus CD20 as Maintenance Therapy, in Elderly Patients With Newly Diagnosed MYC\u002FBCL2 Co-expressor DLBCL","Inclusion Criteria:\n\n1. Age ≥ 70 years;\n2. No prior treatment for DLBCL;\n3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② \"MYC\u002FBCL2 double-expressor\": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-\"double-hit\" or \"triple-hit\" lymphoma;\n4. At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma;\n5. International Prognostic Index (IPI) score \\> 1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;\n7. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, Platelet count (PLT) ≥ 90 × 10⁹\u002FL; ② Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis);\n8. Life expectancy ≥ 6 months;\n9. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) involvement;\n2. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.);\n3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide;\n5. HIV\u002FHCV infection;\n6. If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled.\n7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;\n8. Inability to comply with the study protocol due to psychiatric or other unknown reasons;\n9. For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women;\n10. Other conditions deemed unsuitable for participation in this trial.","ALL","70 Years",{"count":103,"type":104},50,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC\u002FBCL2 double-expressor DLBCL.",[110],"Diffuse Large B-Cell Lymphoma (DLBCL)",[112],"newly diagnosed MYC\u002FBCL2 double-expressor DLBCL","2026-03-20",{"date":115,"type":116},"2026-03-25","ACTUAL",{"date":118,"type":104},"2026-04-30",{"date":120,"type":104},"2029-12-30",{"name":91,"class":6},1]