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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT03677154
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 23, 2019
Status verified
Aug 2025
Primary completion
Aug 7, 2025
Completion
Aug 7, 2025

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Consolidation Therapy (Cohort A)
    Participants with a partial response to first-line chemotherapy will receive mosunetuzumab up to the recommended consolidation dose (RCD).
  • Experimental: Elderly/Unfit Previously Untreated Monotherapy (Cohort B)
    Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab at the previously determined recommended phase II dose (RP2D).
  • Experimental: Elderly/Unfit Previously Untreated Combination Therapy (Cohort C)
    Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab in combination with polatuzumab vedotin.

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: Baseline through approximately 90 days after last study treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham School of MedicineBirminghamAlabama352331912-
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa MonicaSanta MonicaCalifornia90404-2023-
Fort Wayne Medical InstituteFort WayneIndiana46805-
University of Maryland Medical CenterBaltimoreMaryland21201-
Duke UniversityDurhamNorth Carolina27708-9963-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Rhode Island HospitalProvidenceRhode Island02903-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham School of Medicine· Birmingham, ALUniversity of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica· Santa Monica, CAFort Wayne Medical Institute· Fort Wayne, INUniversity of Maryland Medical Center· Baltimore, MDDuke University· Durham, NCFox Chase Cancer Center· Philadelphia, PA

Related Studies