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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 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-08-21

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2025-08-07
Completion
2025-08-07
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Poland
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677154 on ClinicalTrials.gov