Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma

NCT04792502 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BrUOG 401
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

Brief Summary

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

Marginal Zone Lymphoma; B-cell Lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The rate of complete response at the time of primary response assessment (PRA).

  At the end of Cycle 8 (each cycle is 21 days)

Secondary Outcomes (1)

• Progression Free Survival

  Time of study registration through end of follow-up, approximately 5 years.

Study Arms (1)

Planned Therapy

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Lenalidomide

Interventions

Mosunetuzumab DRUG

Administered subcutaneously by injection beginning with 5 mg and increasing to 45 mg.

Planned Therapy

Lenalidomide DRUG

Patients in the augmentation cohort will be dosed continuously, 10 mg orally once daily, with or without food.

Planned Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.
• 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.
• 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.
• Agreement to provide, if available, lymphoma tissue for correlative analyses.
• At least one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \>1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria.
• No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed.
• Indication to start systemic therapy for lymphoma:
• Patients with FL must meet one of the GELF criteria:
• any mass ≥7 cm (except spleen);
• at least 3 nodes \>3 cm in diameter;
• symptomatic spleen enlargement;
• local symptoms or compromise of normal organ function due to tumor mass;
• presence of ascites or pleural effusion;

You may not qualify if:

• Grade 3b follicular lymphoma or transformed lymphoma.
• Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma.
• Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
• Known NYHA class 3/4 congestive heart failure, LVEF \<40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.
• Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.
• History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering \<10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for \>12 months prior to registration.
• Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment using \<10 mg/day prednisone or equivalent within 2 weeks prior to first treatment; a brief course of palliative corticosteroids at higher doses (prednisone up to 100 mg daily, for up to 7 days) is allowed, but must be completed at least 7 days before the first dose of mosunetuzumab.
• Any of the following conditions:
• active bacterial infection requiring antibiotics
• known or suspected chronic active Epstein Barr virus (CAEBV) infection
• history of hemophagocytic lymphohistiocytosis (HLH)
• confirmed progressive multifocal leukoencephalopathy (PML)
• known active EBV or CMV viremia
• positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total/IgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to take entecavir or tenofovir, and undergo periodic DNA testing

Sponsors & Collaborators

• Brown University: lead
• Genentech, Inc.: collaborator

Study Sites (3)

Yale Cancer Center

New Haven, Connecticut, 06511, United States

NOT YET RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Lifespan Cancer Insitute

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Adam J Olszewski, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BrUOG

CONTACT

401-863-3000; BrUOG@Brown.edu

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: March 8, 2021
• First Posted: March 11, 2021
• Study Start: July 14, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-03

Locations

US (3)