drugset / Trial / NCT03677154

Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

NCT03677154

Phase 1/2 Completed 188 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.

Timeline

Start
2019-05-23
Primary completion
2025-08-07
Completion
2025-08-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Mosunetuzumab Monoclonal antibody Intravenous
Subject Polatuzumab Vedotin Other / unclassified Intravenous
Background Tocilizumab Monoclonal antibody Intravenous