drugset / 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
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2022-04-25
- Primary completion
- 2025-02-17
- Completion
- 2027-02-28
Publications
- Maruyama D, Goto H, Kumode T, Aizawa K, Fukuhara N, Westin JR, Kim WS, Mori C, Imaizumi T, Kato K. Efficacy and safety of subcutaneous mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory large B-cell lymphoma: Japan subgroup analysis of the phase III SUNMO trial. Int J Clin Oncol. 2026 Jun 15. doi: 10.1007/s10147-026-03042-x. Online ahead of print.
- Chavez JC, Bastos-Oreiro M, Diefenbach C, Lossos IS, Shah N, Assouline S, Olszewski AJ, Naik S, Ghosh N, Pham S, Wei MC, Batlevi C, To I, Ead W, Makadia S, Penuel E, Jing J, Budde LE. A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. Am J Hematol. 2026 Jun 12. doi: 10.1002/ajh.70403. Online ahead of print.
- Budde LE, Zhang H, Kim WS, Maruyama D, Rego EM, Norasetthada L, Hong H, Ozcan M, Jeon YW, Leao Cordeiro de Farias D, Fogliatto LM, Pavlovsky A, Goto H, Olszewski AJ, Shah N, Hu B, Yin S, Wu H, To I, Ead WS, Ashby J, Janousek M, Pham S, Wang J, Kwan A, Batlevi CL, Wei MC, Westin J. Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial. J Clin Oncol. 2025 Dec 20;43(36):3799-3811. doi: 10.1200/JCO-25-01957. Epub 2025 Oct 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Mosunetuzumab | Monoclonal antibody | — | Subcutaneous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | — | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Tocilizumab | Monoclonal antibody | — | Intravenous |