OncoMatch/Clinical Trials/NCT04792502
Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
Is NCT04792502 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mosunetuzumab and Lenalidomide for follicular lymphoma.
Treatment: Mosunetuzumab · Lenalidomide — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 expression (confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry)
confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-cd20 antibody
Cannot have received: lenalidomide (lenalidomide)
Cannot have received: stem cell transplant
Cannot have received: solid organ transplant
Lab requirements
Blood counts
hemoglobin ≥9 g/dL, absolute neutrophil count ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly)
Kidney function
Glomerular filtration rate (GFR) ≥40 mL/min/1.73m2 using the Mayo Quadratic Formula
Liver function
AST or ALT ≤3x ULN; total bilirubin ≤2x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only); INR ≤1.5x ULN without anticoagulation; PTT or APTT ≤1.5x ULN in the absence of lupus anticoagulant
Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly): hemoglobin ≥9 g/dL, absolute neutrophil count ≥1.0 x 10^9/L, platelet count ≥75 x 10^9/L. ... Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab: AST or ALT >3x ULN, total bilirubin >2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only), INR>1.5 x ULN without anticoagulation, PTT or APTT >1.5x ULN in the absence of lupus anticoagulant. Glomerular filtration rate (GFR) ≥40 mL/min/1.73m2 using the Mayo Quadratic Formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale Cancer Center · New Haven, Connecticut
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- Lifespan Cancer Insitute · Providence, Rhode Island
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify