A Study Evaluating Efifcacy 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 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 (SUNMO)
ClinicalTrials.gov ID: NCT05171647
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2024-03-27
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
Intervention / Treatment:
- Drug: Mosunetuzumab
- Drug: Polatuzumab vedotin
- Drug: Tocilizumab
- Drug: Rituximab
- Drug: Gemcitabine
- Drug: Oxaliplatin
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-04-25 |
| Primary Completion (Estimated) | 2025-05-30 |
| Study Completion (Estimated) | 2027-11-30 |
| Enrollment (Estimated) | 222 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
GO43643
|