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

NCT03677141

Phase 1/2 Completed 117 enrolled Hoffmann-La Roche
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

Drugs

EvaluationDrugModalityDoseRoute
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