OncRef

Clinical Trial: NCT05171647

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-08-05

Study Overview

Brief Summary

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

Official Title

A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Conditions

Non-Hodgkin Lymphoma

Intervention / Treatment

  • Drug: Mosunetuzumab
  • Drug: Polatuzumab vedotin
  • Drug: Tocilizumab
  • Drug: Rituximab
  • Drug: Gemcitabine
  • Drug: Oxaliplatin

Other Study ID Numbers

  • GO43643

Start Date (Actual)

2022-04-25

Primary Completion Date (Actual)

2025-02-17

Study Completion Date (Estimated)

2027-02-28

Enrollment (Actual)

208

Study Type

Interventional

Phase

Phase 3