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NOT YET RECRUITING
NCT07034508
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Polatuzumab Vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

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