Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05169658
Phase
PHASE2
Status
Completed

Conditions

  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Indolent B-Cell Non-Hodgkin Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin Lymphoma
  • Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Eligibility Criteria

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

Interventions

  • Mosunetuzumab — BIOLOGICAL
    Given SC
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Polatuzumab Vedotin — DRUG
    Given IV
  • FDG-Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET and FDG-PET/CT
  • Computed Tomography — PROCEDURE
    Undergo CT and FDG-PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT and FDG-PET/CT
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase II trial tests the effects of mosunetuzumab with or without polatuzumab vedotin and obinutuzumab for the treatment of patients with indolent B-cell non-Hodgkin lymphoma. Mosunetuzumab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79b receptors, and delivers vedotin to kill them. Giving mosunetuzumab with polatuzumab vedotin and obinutuzumab may work better in treating patients with untreated indolent B-cell non-Hodgkin lymphoma.

Key Dates

Start date
Mar 23, 2022
Status verified
Apr 2026
Primary completion
Apr 2, 2025
Completion
Apr 2, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (mosunetuzumab, obinutuzumab, polatuzumab vedotin)
    PART A: Patients receive mosunetuzumab SC over 30 seconds - 2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT, PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab IV on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study.

Primary Outcome Measure

Complete Response (CR) [ Time Frame: At the end of treatment completion, an average of 5.5 months after starting treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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