Polatuzumab Vedotin Combo for Lymphoma
(POLARGO Trial)
Trial Summary
What is the purpose of this trial?
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma who have had at least one prior therapy. They should not be planning a stem cell transplant, must agree to use contraception if of childbearing potential, and cannot have severe allergies to monoclonal antibodies or certain chemotherapy drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Safety of polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin is assessed in 10 participants
Randomized Controlled Trial (RCT)
Comparison of Pola-R-GemOx versus R-GemOx alone using overall survival as the primary endpoint
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gemcitabine
- Oxaliplatin
- Polatuzumab Vedotin
- Rituximab
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
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