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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).
DRUG	Polatuzumab vedotin	Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).
DRUG	Tocilizumab	Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.
DRUG	Rituximab	Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
DRUG	Gemcitabine	Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).
DRUG	Oxaliplatin	Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

Timeline

• Start date: 2022-04-25
• Primary completion: 2025-02-17
• Completion: 2027-02-28
• First posted: 2021-12-29
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

53 sites across 13 countries: United States, Argentina, Brazil, Canada, China, Israel, Japan, Mexico, New Zealand, Peru, South Korea, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study