Actively Recruiting
Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
Led by Brown University · Updated on 2025-12-30
52
Participants Needed
3
Research Sites
267 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).
CONDITIONS
Official Title
Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent and follow study procedures
- Age 18 years or older at consent
- Confirmed diagnosis of follicular lymphoma (grade 1, 2, 3a, or unspecified) or marginal zone lymphoma (nodal, extranodal, or splenic) expressing CD20
- Willing to provide lymphoma tissue if available for analysis
- At least one measurable lymph node lesion larger than 1.5 cm or extranodal lesion larger than 1.0 cm; splenic MZL must be evaluable by specific criteria
- No prior systemic therapy for B-cell lymphoma except palliative corticosteroids; prior local treatments allowed
- Indication to start systemic therapy based on GELF criteria for FL or investigator assessment for MZL
- ECOG performance status 0, 1, or 2
- Adequate blood counts unless affected by lymphoma
- Glomerular filtration rate of 40 mL/min/1.73m2 or higher
- Agreement to use contraception and comply with lenalidomide REMS program
You will not qualify if you...
- Grade 3b follicular lymphoma or transformed lymphoma
- Prior treatment with anti-CD20 antibody or lenalidomide for lymphoma
- Previous stem cell or solid organ transplant
- History of severe allergic reactions to monoclonal antibodies or murine products
- Severe heart failure, recent heart attack, unstable angina, or arrhythmia
- Chronic obstructive pulmonary disease requiring steroids or oxygen
- History of autoimmune diseases except stable or mild cases specified
- Use of systemic immunosuppressive drugs beyond allowed corticosteroids
- Active infections including hepatitis B, C, HIV, or other serious viral infections
- Recent live vaccine administration
- CNS diseases or advanced neurodegenerative disease except stable conditions specified
- Other malignancies affecting study compliance except certain treated cancers
- Significant liver disease or alcohol abuse
- Major surgery within 4 weeks before treatment except diagnostic biopsy
- Uncontrolled medical or psychiatric conditions
- Abnormal liver function or coagulation tests
- Recent radiation therapy
- Pregnancy, breastfeeding, or prisoner status
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Not Yet Recruiting
2
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
3
Lifespan Cancer Insitute
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
B
BrUOG
CONTACT
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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