[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595596":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":52,"responsibleParty":67,"collaborators":29,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":29,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":29,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":29,"overallStatus":88,"whyStopped":29,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"4×Pola-RCHP followed by 2×Pola-R","EXPERIMENTAL","Participants will receive:\n\nPolatuzumab Vedotin: 1.8 milligrams per kilogram (mg\u002Fkg) intravenously (IV) on Day 1 of every cycle for 6 cycles.\n\nRituximab: 375 milligrams per square meter (mg\u002Fm\\^2) IV on Day 1 of every cycle for 6 cycles.\n\nCyclophosphamide: 750 mg\u002Fm\\^2 IV on Day 1 of every cycle for 4 cycles. Doxorubicin: 50 mg\u002Fm\\^2 IV on Day 1 of every cycle for 4 cycles. Prednisone: 100 milligrams per day (mg\u002Fday) orally (PO) on Days 1-5 of each 21-day cycle for 4 cycles.\n\nThis Pola-RCHP regimen is repeated for 4 cycles, followed by 2 cycles of Polatuzumab Vedotin and Rituximab.",[13,14,15,16,17],"Drug: Polatuzumab Vedotin","Drug: Rituximab","Drug: Cyclophosphamide","Drug: Doxorubicin","Drug: Prednisone",{"label":19,"type":20,"description":21,"interventionNames":22},"6×Pola-RCHP","ACTIVE_COMPARATOR","Participants will receive:\n\nPolatuzumab Vedotin: 1.8 milligrams per kilogram (mg\u002Fkg) intravenously (IV) on Day 1 of every cycle for 6 cycles.\n\nRituximab: 375 milligrams per square meter (mg\u002Fm\\^2) IV on Day 1 of every cycle for 6 cycles.\n\nCyclophosphamide: 750 mg\u002Fm\\^2 IV on Day 1 of every cycle for 6 cycles. Doxorubicin: 50 mg\u002Fm\\^2 IV on Day 1 of every cycle for 6 cycles. Prednisone: 100 milligrams per day (mg\u002Fday) orally (PO) on Days 1-5 of each 21-day cycle for 6 cycles.\n\nThis regimen is repeated for 6 cycles",[13,14,15,16,17],[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Polatuzumab Vedotin","Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.",[9,19],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Rituximab","Rituximab IV infusion will be administered as per the schedule specified in the respective arm.",[9,19],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Cyclophosphamide","Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm",[9,19],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Doxorubicin","Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.",[9,19],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Prednisone","Prednisone PO will be administered as per the schedule specified in the respective arm.",[9,19],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Liang Huang","CONTACT","13971600192","huangliang@ihcams.ac.cn",[53],{"facility":54,"status":29,"city":55,"state":29,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"China Institute of Hematology and Blood Diseases Hospital","Tianjin","300020","China","CN",{"type":60,"coordinates":61},"Point",[62,63],117.17667,39.14222,{"lat":63,"lon":62},[66],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},{"type":68,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100595596","phase-2-a-phase-ii-trial-of-4-vs-6-cycles-of-chp-combined-with-polatuzumab-vedotin-rituximab-in-untreated-dlbcl-patients-with-ipi-0-1-100595596",false,"NCT07034508","A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1","An Open-Label, Multicentre, Randomized Phase II Non-Inferiority Trial Comparing 4 vs 6 Cycles of CHP (21-Day Intervals) Both Combined With 6 Cycles of Polatuzumab Vedotin and Rituximab in Previously Untreated Diffuse Large B-Cell Lymphoma Patients With IPI 0-1","Inclusion Criteria:\n\n* Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL)\n* Age ≥18yo and ≤80yo at the time of signing consent\n* International Prognostic Index (IPI) score 0-1\n* ECOG 0-2\n* Have measurable disease on a pre-chemotherapy PET\u002FCT, defined as at least one bi-dimensionally measurable nodal lesion of \\>1.5cm in longest dimension, or at least one bi-dimensionally measurable extranodal lesion of \\>1.0cm in longest dimension\n* Life expectancy greater than or equal to (\\>\u002F=)12 months\n* Left ventricular ejection fraction (LVEF) \\>\u002F= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Adequate hematologic function\n* Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.\n* Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n* Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma.\n* Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.\n* Pregnant or lactating women.\n* Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction \\[PCR\\]) infection.\n* Patients with concurrent other tumors or a history of tumors, or who have received anti-tumor treatment (including major surgery) within the last 4 weeks.\n* Allergic reactions to polatuzumab vedotin.\n* Other conditions where the investigator deems the patient ineligible for this study.","ALL","18 Years","80 Years",{"count":80,"type":81},134,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab",[87],"DLBCL - Diffuse Large B Cell Lymphoma","NOT_YET_RECRUITING","2025-06-15",{"date":91,"type":92},"2025-06-24","ACTUAL",{"date":94,"type":81},"2025-06-20",{"date":96,"type":81},"2029-12-20",{"name":5,"class":6},1]