Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Minor Study completion pushed from Jul 15, 2026 to Jul 15, 2027
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 2 of 3 sites
  2. Minor Study completion date: Apr 30, 2026 to Jul 15, 2026v13
  3. Notable Results first posted: Aug 6, 2025v12
  4. Minor Secondary endpoints: details revised at 5 of 5 entriesv11
  5. Minor Primary completion date changed from estimate of Sep 6, 2024 to Jun 6, 2022
    • Secondary endpoints revised (5)
    • Primary endpoint revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary completion date: Sep 6, 2023 to Sep 6, 2024v9
  2. Minor Collaborators: 1 to 3v8
  3. Notable Primary completion date: Oct 19, 2022 to Sep 6, 2023v7
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 27 to confirmed 23
    • Site details revised at 3 of 3 sites
    v6
  5. Notable Primary completion date: Oct 30, 2021 to Oct 19, 2022v5
  6. Notable Primary completion date: Apr 30, 2021 to Oct 30, 2021v4
  7. Minor Re-verified, no change to tracked fieldsv3
  8. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Aug 31, 2022 to Apr 30, 2021
    • Study sites: 2 to 3
    • Study completion date: Mar 31, 2027 to Apr 30, 2026
    • Start date changed from estimate of Mar 1, 2020 to Apr 11, 2019
    • Eligibility criteria expanded, about 7 words
  1. Minor Study First Submitted
  • 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.
This phase II trial studies how well bendamustine, obinutuzumab, and venetoclax work in treating patients with mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving bendamustine, obinutuzumab, and venetoclax may work better in treating patients with mantle cell lymphoma.
Trial Details
NCT Number NCT03872180
Lead Sponsor Emory University
Collaborators: Genentech, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)
Conditions
(from sponsor)
CCND1 Positive, Mantle Cell Lymphoma, t(11;14) Positive
Related terms Lymphoma, Mantle-Cell
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov