drugset / Trial / NCT03677141
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
Timeline
- Start
- 2019-03-08
- Primary completion
- 2023-10-12
- Completion
- 2023-10-12
Outcome
Missed primary endpoint
registry Difference in rates -4.77 (95% CI -30.61 to 21.07) NCT03677141 ↗
paper Pola-M-CHP, although an active combination, did not demonstrate a clinical benefit over Pola-R-CHP in this small study. PMID 39908481 ↗
Publications
- Westin J, Phillips TJ, Mehta A, Hoffmann MS, Gonzalez-Barca E, Thieblemont C, Bastos-Oreiro M, Greil R, Giebel S, Wei MC, Wang J, Bucher R, Sit J, Penuel E, Purev E, Yee DL, Bergua-Burgues JM. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study. Blood Adv. 2025 May 27;9(10):2461-2472. doi: 10.1182/bloodadvances.2024014907.
- Olszewski AJ, Phillips TJ, Hoffmann MS, Armand P, Kim TM, Yoon DH, Mehta A, Greil R, Westin J, Lossos IS, Munoz JL, Sit J, Wei MC, Yang A, Chen V, Purev E, Yee DL, Jaeger U. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study. Blood Adv. 2023 Oct 24;7(20):6055-6065. doi: 10.1182/bloodadvances.2023010840.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mosunetuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | — | Intravenous |
| Comparator | Rituxumab | Unknown | — | Intravenous |
| Subject | Vincristine | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Tocilizumab | Monoclonal antibody | — | Intravenous |