Polatuzumab Vedotin + R-CHP vs R-CHOP for Diffuse Large B-Cell Lymphoma
(POLARIX Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using corticosteroids at more than 30 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control, you may need to adjust this. Also, if you have used any monoclonal antibodies recently, you might need to wait before starting the trial.
What data supports the effectiveness of the drug Polatuzumab Vedotin + R-CHP for treating Diffuse Large B-Cell Lymphoma?
Research shows that Polatuzumab Vedotin combined with R-CHP significantly improves progression-free survival (the time during and after treatment that a patient lives with the disease without it getting worse) compared to the standard R-CHOP treatment in patients with Diffuse Large B-Cell Lymphoma. This means patients on Polatuzumab Vedotin + R-CHP tend to have a longer period without the disease progressing.12345
Is Polatuzumab Vedotin + R-CHP safe for humans?
In a study comparing Polatuzumab Vedotin combined with R-CHP to the standard R-CHOP treatment for diffuse large B-cell lymphoma, the safety was found to be similar between the two groups. Both treatments had comparable rates of serious side effects, including severe adverse events and peripheral neuropathy (nerve damage).12367
How is the drug Polatuzumab Vedotin + R-CHP different from other treatments for diffuse large B-cell lymphoma?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive polatuzumab vedotin plus R-CHP or R-CHOP for 6 cycles, with additional rituximab monotherapy in Cycles 7 and 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Polatuzumab Vedotin
- Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP)
- Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Polatuzumab Vedotin is already approved in United States, European Union for the following indications:
- Diffuse large B-cell lymphoma (DLBCL)
- High-grade B-cell lymphoma (HGBL)
- Diffuse large B-cell lymphoma (DLBCL)
- High-grade B-cell lymphoma (HGBL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
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