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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Primary completion date: Aug 1, 2025 to Aug 31, 2027
    • Study completion date: Aug 1, 2027 to Aug 31, 2027
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Site details revised at 1 of 3 sitesv10
  5. Eligibility criteria expanded, about 2 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site contacts updated at 1 of 3 sites
    • Eligibility criteria expanded, about 2 words
    v8
  2. Site contacts updated at 1 of 3 sitesv7
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Start date changed from estimate of Jul 1, 2022 to Jul 14, 2022
    • Eligibility criteria expanded, about 127 words
    • Site details revised at 3 of 3 sites
    • Collaborators expanded, about 2 words
  4. Start date: May 1, 2022 to Jul 1, 2022v5
  5. Primary completion date: Aug 1, 2024 to Aug 1, 2025
    • Start date: Apr 1, 2022 to May 1, 2022
    • Study completion date: Aug 1, 2026 to Aug 1, 2027
    v4
  6. Re-verified, no change to tracked fieldsv3
  7. Lead sponsor: Adam Olszewski to Brown University
    • Start date: Aug 1, 2021 to Apr 1, 2022
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04792502
Lead Sponsor Brown University
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Follicular Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma
Related terms Lymphoma, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov