Polatuzumab Vedotin + R-CHP vs R-CHOP for Diffuse Large B-Cell Lymphoma

(POLARIX Trial)

Recruiting at324 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with previously untreated CD20-positive diffuse large B-cell lymphoma. Participants must have a life expectancy of at least 12 months, good heart function (LVEF ≥50%), and an ECOG Performance Status of 0-2. They should agree to use contraception and not donate sperm or eggs. Exclusions include prior organ transplants, certain other lymphomas, CNS involvement, recent live vaccines, significant ECG abnormalities, major surgery within the last month, HIV or hepatitis infection among others.

Inclusion Criteria

International Prognostic Index (IPI) score of 2-5

I am able to care for myself and perform daily activities.

My heart pumps well, with an ejection fraction of 50% or more.

Exclusion Criteria

I have had treatment for DLBCL, but only a node biopsy.

I have not received any live vaccines in the last 28 days.

I do not have any active infections or significant infections in the last 2 weeks.

Treatment Details

Interventions

• Polatuzumab Vedotin (Monoclonal Antibodies)
• Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) (Chemotherapy)
• Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) (Chemotherapy)

Trial Overview The study compares Polatuzumab Vedotin combined with R-CHP versus the standard R-CHOP therapy in treating diffuse large B-cell lymphoma. It's a Phase III trial where participants are randomly assigned to either treatment group in a double-blind manner; neither they nor the researchers know who receives which treatment until after the results are collected.

Participant Groups

Group I: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin Experimental Treatment 6 Interventions

Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m\^2) IV, cyclophosphamide 750 mg/m\^2 IV, and doxorubicin 50 mg/m\^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Group II: R-CHOP plus Polatuzumab Vedotin Placebo Placebo Group 6 Interventions

Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m\^2 IV, cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV (maximum 2 milligrams per dose \[mg/dose\]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University