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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

The POLARIX study demonstrated that the Pola-R-CHP regimen (replacing vincristine in R-CHOP with Pola) significantly improves progression-free survival (PFS) and is safer than traditional R-CHOP. The FLYER study suggested that 4 cycles of R-CHOP followed by 2 additional doses of rituximab in young, low-risk DLBCL patients (IPI 0-1) are as effective as 6 cycles of R-CHOP and result in lower toxicity. Based on the efficacy of Pola-R-CHP and the potential for reducing treatment intensity in low-risk patients, this study will evaluate whether 4 cycles of Pola-R-CHP followed by 2 cycles of Pola-R are non-inferior to 6 cycles of Pola-R-CHP in treatment-naive low-risk DLBCL patients (IPI 0-1), with a potentially better safety profile.

Conditions

• DLBCL - Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-12-20
• Completion: 2029-12-20
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China