Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma
A Pilot Study of Subcutaneous Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for Untreated Indolent B-Cell Non-Hodgkin Lymphoma
3 other identifiers
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
December 27, 2021
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2025
CompletedApril 11, 2025
April 1, 2025
3 years
December 9, 2021
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response (CR)
A simple binary proportion will be used to estimate CR.
Up to 5 years
Secondary Outcomes (1)
Overall response rate (ORR)
Up to 5 years
Study Arms (1)
Treatment (mosunetuzumab, obinutuzumab, polatuzumab vedotin)
EXPERIMENTALPART 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.
Interventions
Given SC
Given IV
Given IV
Undergo FDG-PET and FDG-PET/CT
Undergo CT and FDG-PET/CT
Undergo PET/CT and FDG-PET/CT
Undergo bone marrow biopsy
Undergo bone marrow aspiration
Undergo blood sample collection
Eligibility Criteria
You may qualify if:
- Diagnosis of indolent B-cell non-Hodgkin lymphoma with no prior systemic therapy.
- \* Eligible histologies based on 2016 World Health Organization (WHO) classification include:
- Follicular lymphoma (grade 1-2 or 3a)
- Marginal zone lymphoma. Patients with mucosa-associated lymphoid tissue (MALT) subtype of marginal zone lymphoma (MZL) may have relapsed or refractory disease after a course of antibiotic therapy
- Meet criteria for initiation of therapy that include one of the following:
- Symptomatic disease (including but not limited to pain/discomfort, b-symptoms)
- Threatened end-organ function
- Progressive cytopenias (leukopenia \[WBC \< 1,000/uL\] OR hemoglobin \< 10 g/dL OR platelets \< 100,000/uL)
- Steady progression
- Bulky disease (one site at least 7 cm or at least four sites of 3 cm)
- Hepatomegaly
- Splenomegaly
- Be willing and able to provide written informed consent for the trial
- Have had an informed discussion with the investigator as part of the consenting/screening process that included information on treatments for these conditions with known clinical benefit, and there is documented understanding that the patient is forgoing approved available therapies
- Be \>= 18 years of age on day of signing informed consent
- +14 more criteria
You may not qualify if:
- Contraindication to any of the individual components of this regimen or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
- Prior systemic treatment for lymphoma with the exception of corticosteroids as outlined below. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response
- Absolute lymphocyte count \> 5000/uL
- History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Patients with a remote history of, or well-controlled autoimmune disease, may be eligible to enroll after discussion with and confirmation by the principal investigator. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study
- Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- Rash must cover \< 10% of body surface area. Disease is well controlled at baseline and requires only low-potency topical corticosteroids. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
- Prior solid organ transplantation
- Current grade \>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
- Prior use of any monoclonal antibody within 3 months of the start of cycle 1; any investigational therapy within 28 days prior to the start of cycle 1; vaccination with live vaccines within 28 days prior the start of cycle 1
- Prior corticosteroid use for conditions related or unrelated to lymphoma are allowed provided that at least 14 days have lapsed since last dose and initiation of study therapy, except for patients who require corticosteroid pre-medication for IV contrast administration
- History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:
- Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Genentech, Inc.collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Lynch, MD
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2021
First Posted
December 27, 2021
Study Start
March 23, 2022
Primary Completion
April 2, 2025
Study Completion
April 2, 2025
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share