Actively Recruiting
Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
Led by University of Washington · Updated on 2026-03-13
20
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
CONDITIONS
Official 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)
- Eligible lymphoma types include follicular lymphoma (grade 1-2 or 3A) and marginal zone lymphoma
- Ann Arbor stage II-IV disease
- Low tumor burden disease by GELF criteria: tumor mass less than 7 cm, involvement of fewer than 3 nodal sites over 3 cm, no systemic or B symptoms, no splenomegaly greater than 16 cm, no vital organ compression risk, no pleural or peritoneal effusions, no leukemic phase (circulating lymphocytes less than 5,000/uL), 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 FDG-avid extranodal site at least 1.0 cm; spleen size more than 13 cm vertical length also counts
- ECOG performance status 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 in Gilbert's syndrome)
- AST, ALT, and GGT no more than 3 times upper normal limit
- Negative pregnancy test within 7 days before starting mosunetuzumab for women of childbearing potential
- Fertile males and females of childbearing potential agree to use effective contraception from treatment start to 3 months after last dose
You will not qualify if you...
- History of severe allergic reaction to monoclonal antibody therapy
- History of a second primary malignancy that could affect study compliance or results without principal investigator permission
- Active uncontrolled infections including bacterial, viral, fungal, mycobacterial, or other infections
- HIV infection unless viral load is undetectable and CD4 count is at least 200
- Positive test for chronic hepatitis B infection (positive HBsAg); patients with prior or occult infection may be included if HBV DNA is undetectable and monthly testing and antiviral therapy are accepted
- Autoimmune disease requiring active treatment
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Significant other diseases or medical conditions that could interfere with the study or risk patient safety, including severe heart or lung disease
- Ongoing systemic corticosteroids above 10 mg/day prednisone equivalent except for non-tumor, non-immunosuppressive uses
- Prior monoclonal antibody use within 4 weeks before first mosunetuzumab dose
- Prior solid organ transplantation
- Pregnant or breastfeeding women or intending to become pregnant during study or within 3 months after last dose of mosunetuzumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here