Title: A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine, and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (POLARGO)
Study Director: Clinical Trials Hoffmann-La Roche
Description: Researchers are evaluating the safety and efficacy of polatuzumab vedotin in combination with rituximab, gemcitabine, and oxaliplatin (Pola-R-GemOx) compared with R-GemOx alone in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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The multicenter, open-label, phase 3 trial consists of 2 stages: a safety run-in stage and a randomized controlled trial (RCT). The safety run-in stage (stage 1) is designed to assess the safety of Pola-R-GemOx. In the RCT (stage 2), researchers will compare Pola-R-GemOx with R-GemOx.
The primary outcome measures include overall survival and the percentage of patients with adverse events. Secondary endpoints include progression-free survival, response outcomes, and safety outcomes, among other endpoints.
To be eligible for enrollment, patients must have histologically confirmed DLBCL not otherwise specified or a history of transformation from indolent disease to DLBCL. For a complete list of eligibility criteria, please refer to the reference.
Status: Recruiting
This study is sponsored by Hoffmann-La Roche.
Reference
Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (POLARGO). NCT04182204. Accessed August 16, 2021.
