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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

NCT07034508 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-06-24

No results posted yet for this study

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

Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2027-12-20
Completion
2029-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034508 on ClinicalTrials.gov