drugset / Trial / NCT04182204
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
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2020-02-07
- Primary completion
- 2024-11-29
- Completion
- 2024-11-29
Outcome
Met primary endpoint
registry analysis (superiority test); Stage 2: R-GemOx vs Stage 2: Pola-R-GemOx; p = 0.0017; Hazard Ratio (HR) 0.60 (95% CI 0.43 to 0.83); Log Rank NCT04182204 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Polatuzumab Vedotin | Other / unclassified | 1.8 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |