[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632240":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":17,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":17,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":17,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":17,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Innovative Treatment Group","EXPERIMENTAL","The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.\n\nPerform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.\n\nFor patients with C1D14 ctDNA LFC \\\u003C 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.",[13],"Drug: C-Pola-R-CHP+X",{"label":15,"type":16,"description":17,"interventionNames":18},"CR-CHOP","ACTIVE_COMPARATOR",null,[19],"Drug: CR-CHOP",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":17},"DRUG","C-Pola-R-CHP+X","The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment.\n\nPerform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles.\n\nFor patients with C1D14 ctDNA LFC \\\u003C 3, stratification is based on gene subtypes, namely C1, C2-3, and TP53mut, which determines the medication for the remaining 5 cycles. For C1 subtype, a PD1 inhibitor is added; for C2 and C3 subtypes, a BTK inhibitor is added; for TP53mut subtype, decitabine is added.",[9],{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":17},"If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":17,"email":34},"Li Wang","CONTACT","18917762217","dr_wangli@126.com",[36],{"facility":37,"status":17,"city":38,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"No. 197 Ruijin 2nd Road, Huangpu District, Shanghai, Shanghai, Shanghai","Shanghai","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":31,"role":32,"phone":33,"phoneExt":17,"email":34},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Principal Investigator","100632240","phase-3-a-study-comparing-c-pola-r-chpx-with-cr-chop-in-the-treatment-of-previously-untreated-del-under-the-guidance-of-genotyping-100632240",false,"NCT07511114","A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping","A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping","Inclusion Criteria:\n\n* 1\\. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;\n* 2\\. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%\n* 3\\. Age ≥ 18 years old and ≤ 75 years old;\n* 4\\. ECOG performance status score of 0, 1, or 2;\n* 5\\. International Prognostic Index (IPI) \\> 1\n* 6\\. No history of malignant tumor; no concurrent occurrence of other tumors;\n* 7\\. Patients with an expected lifespan of at least 6 months, as determined by the researcher;\n* 8\\. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures in the study.\n\nExclusion Criteria:\n\n* 1\\. Have previously received systemic or local treatments, including chemotherapy;\n* 2\\. Have previously undergone autologous stem cell transplantation;\n* 3\\. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;\n* 4\\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;\n* 5\\. Primary central nervous system lymphoma;\n* 6\\. Left ventricular ejection fraction (LVEF) is less than or equal to 50%;\n* 7\\. Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count \\\u003C1.5\\*10\\^9\u002FL; B. Platelet count \\\u003C 75 x 10\\^9\u002FL; C. ALT or AST is 2 times higher than the upper limit of normal, and AKP and bilirubin are 1.5 times higher than the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;\n* 8\\. Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.\n* 9\\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;\n* 10\\. Pregnant or lactating women;\n* 11\\. Individuals infected with HIV.\n* 12\\. Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;","ALL","18 Years","75 Years",{"count":64,"type":65},156,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL",[71,72],"DLBCL - Diffuse Large B Cell Lymphoma","Double Expressor Lymphoma",[74,75,76],"DLBCL","DEL","Chidamide","NOT_YET_RECRUITING","2026-03-31",{"date":80,"type":81},"2026-04-06","ACTUAL",{"date":78,"type":65},{"date":84,"type":65},"2030-03-31",{"name":5,"class":6},1]