NCT03274492

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Conditions

• 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	Vincristine	Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Vincristine Placebo	Placebo matching to vincristine 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.
DRUG	Polatuzumab vedotin Placebo	Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2017-11-16
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2017-09-07
• Last updated: 2026-02-06

Locations

215 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Italy, Japan, New Zealand, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study