drugset
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

NCT04182204 ↗

Phase 3 Completed 270 enrolled Hoffmann-La Roche
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

Drugs

EvaluationDrugModalityDoseRoute
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

Indications

diffuse large B-cell lymphoma