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A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2025-06-20
Completion Date
2029-12-20
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
Polatuzumab Vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Locations (1)
China Institute of Hematology and Blood Diseases Hospital
Tianjin, China