NCT04792502 · Brown University
Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
What this study is about
BrUOG-401 is a forward-looking, single-treatment group$1, 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.
View original scientific description
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.
Interventions
DRUG
Mosunetuzumab
Administered subcutaneously by injection beginning with 5 mg and increasing to 45 mg.
DRUG
Lenalidomide
Patients in the augmentation cohort will be dosed continuously, 10 mg orally once daily, with or without food.
Primary outcome measures
Complete Response Rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
The rate of complete response at the time of primary response assessment (PRA).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures. 2. Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients \<18 years of age, they are excluded from this study. 3. Histologically confirmed diagnosis of:
- follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or
- marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL/MZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis. 4. Agreement to provide, if available, lymphoma tissue for correlative analyses. 5. At least o
Where
- New Haven, Connecticut
- New Brunswick, New Jersey
- Providence, Rhode Island
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 30, 2025 · Source of record for eligibility and locations