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

A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients With Diffuse Large B-Cell Lymphoma Following First-Line Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 188 (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 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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab Intravenous (IV)	Participants in cohorts A and B will receive IV mosunetuzumab.
DRUG	Mosunetuzumab Subcutaneous (SC)	Participants in Cohort C will receive SC mosunetuzumab.
DRUG	Polatuzumab Vedotin	Participants in Cohort C will receive IV polatuzumab vedotin.
DRUG	Tocilizumab	Participants will receive tocilizumab via IV as needed to manage severe cytokine release syndrome (CRS).

Timeline

• Start date: 2019-05-23
• Primary completion: 2025-08-07
• Completion: 2025-08-07
• First posted: 2018-09-19
• Last updated: 2025-08-21

Locations

32 sites across 6 countries: United States, Israel, Poland, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study