Actively Recruiting
Low Dose Mosunetuzumab for Indolent B-Cell Lymphoma
Led by University of Washington · Updated on 2026-03-13
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, side effects, and effectiveness of mosunetuzumab in treating patients with slow-growing (indolent) B-cell lymphoma, including follicular lymphoma and marginal zone lymphoma at Ann Arbor stages II-IV. Mosunetuzumab is a monoclonal antibody that may affect how tumor cells grow and spread. This phase II trial focuses on patients with specific low-tumor burden lymphoma who have not received prior therapy for their lymphoma. Participants receive mosunetuzumab intravenously over 2 to 4 hours on days 1, 8, 15, and 22. Alongside treatment, patients undergo blood sample collections and imaging tests including positron emission tomography (PET)/computed tomography (CT). Additional imaging such as CT and magnetic resonance imaging (MRI) and the collection of oral or rectal swabs may be performed as needed. After treatment, patients are followed up at week 13, at 6 months, and then up to 5 years according to institutional standards. During the study, researchers monitor the overall response to treatment up to week 13 and assess safety by tracking adverse events and specific syndromes within 30 days after the last dose. Long-term outcomes such as progression-free survival, duration of response, and time to next lymphoma or cytotoxic treatment are also evaluated over a 5-year period. Participants are regularly assessed through blood tests, imaging scans, and questionnaires to understand treatment effects and side effects throughout the study duration.
CONDITIONS
Brief Title
Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at time of signing informed consent
- Able to understand and provide written informed consent
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior lymphoma therapy (prior peptide-based vaccines allowed)
- Diagnosed with follicular lymphoma (grade 1-2 or 3A) or marginal zone lymphoma
- Ann Arbor stage II-IV disease
- Low tumor burden disease by GELF criteria: nodal or extranodal tumor mass less than 7 cm, fewer than 3 nodal sites over 3 cm, no systemic or B symptoms, no splenomegaly over 16 cm, no vital organ compression risk, no pleural or peritoneal effusions, no leukemic phase
- No significant cytopenias: platelets at least 100,000/uL, hemoglobin at least 10 g/dL, ANC at least 1500/uL
- Measurable nodal disease with at least one site 1.5 cm or larger on CT or FDG-PET, or spleen size over 13 cm vertically
- ECOG performance status of 0-2
- Creatinine clearance at least 50 mL/min
- Total bilirubin no more than 1.5 times upper normal limit (up to 3 times allowed for Gilbert's syndrome)
- AST, ALT, and GGT no more than 3 times upper normal limit
- Negative pregnancy test within 7 days before starting treatment for women of childbearing potential
- Fertile males and women of childbearing potential must agree to use effective contraception during and 3 months after treatment
You will not qualify if you...
- History of severe allergic reaction to monoclonal antibody therapy
- History of second primary malignancy that could interfere with study except with investigator permission
- Active uncontrolled infection at enrollment
- HIV infection unless viral load undetectable and CD4 count at least 200
- Positive chronic hepatitis B surface antigen test; occult or prior hepatitis B allowed with monitoring
- Autoimmune disease requiring active therapy
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Significant concurrent medical conditions such as severe heart or lung disease
- Ongoing systemic corticosteroid treatment above 10 mg/day prednisone equivalent
- Use of any monoclonal antibody within 4 weeks before first dose
- Prior solid organ transplant
- Pregnant or breastfeeding women, or intending pregnancy during study or within 3 months after last dose
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 4 weeks
Participants receive mosunetuzumab intravenously over 2 to 4 hours on days 1, 8, 15, and 22. Blood sample collection and PET/CT scans are performed during the study. Participants may also undergo CT and/or MRI scans as clinically indicated and may provide oral and/or rectal swabs.
4 visits (in-person) for treatment dosing and assessments
Duration - Up to 5 years
After completing treatment, participants are followed up at week 13, at 6 months, and then for up to 5 years per institutional standards to monitor long-term outcomes and safety.
Visits at week 13, 6 months, and periodically up to 5 years
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Ajay Gopal
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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