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

A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	Participants will receive intravenous (IV) mosunetuzumab.
DRUG	Polatuzumab Vedotin	Participants will receive polatuzumab vedotin via IV.
DRUG	Rituxumab	Participants will receive rituxumab via IV.
DRUG	Cyclophosphamide	Participants will receive cyclophosphamide via IV.
DRUG	Doxorubicin	Participants will receive doxorubicin via IV.
DRUG	Vincristine	Participants will receive vincristine via IV.
DRUG	Prednisone	Participants will receive oral prednisone.
DRUG	Tocilizumab	Participants will receive tocilizumab via IV.

Timeline

• Start date: 2019-03-08
• Primary completion: 2023-10-12
• Completion: 2023-10-12
• First posted: 2018-09-19
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

41 sites across 6 countries: United States, Austria, France, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study