CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 52 target
Drug / intervention
Mosunetuzumab +1 moredrug
Likely dose
Mosunetuzumab 5 mgfrom record
Key inclusion· 9
  • ✓Histologically confirmed follicular lymphoma (grades 1, 2, 3a) or marginal zone lymphoma (nodal, extranodal, splenic) with CD20 expression
  • ✓At least one bi-dimensionally measurable nodal lesion >1.5 cm or extranodal lesion >1.0 cm
  • ✓No prior systemic therapy for B-cell lymphoma except palliative corticosteroids; prior local therapy allowed
  • ✓Meets indication to start systemic therapy (FL must meet GELF criteria; MZL per investigator assessment)
Key exclusion· 18
  • ✕Grade 3b follicular lymphoma or transformed lymphoma
  • ✕Prior anti-CD20 antibody or lenalidomide for lymphoma
  • ✕Prior stem cell or solid organ transplantation
  • ✕Severe allergic/anaphylactic reaction to humanized or murine monoclonal antibodies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04792502Phase 2RecruitingOn TrackUpdated 6mo ago
Long Recruiting
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BrUOG 401: A Phase 2 Study of Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma

Brown University·interventional·Posted Mar 11, 2021·Updated Dec 30, 2025

In Brief

A Phase 2 clinical trial evaluating Mosunetuzumab and Lenalidomide for Follicular Lymphoma and 2 related conditions. Currently recruiting, targeting 52 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2Recruiting
202220232024202520262027
First PostedMar 11, 2021
Enrollment StartJul 14, 2022
Primary CompletionAug 31, 2027
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 5.3 years agoPrimary completion in 1.2 years

Interventions

Mosunetuzumabdrug

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

Lenalidomidedrug

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