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Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv9
  2. Minor Start date changed from estimate of Dec 10, 2024 to Dec 2, 2024v8
  3. Notable Start date: Sep 10, 2024 to Dec 10, 2024 Primary and study completion dates: Sep 30, 2026 to Oct 16, 2026v7 Show 1 more changeShow less
    • Primary and study completion dates: Sep 30, 2026 to Oct 16, 2026
  4. Notable Start date: Jun 10, 2024 to Sep 10, 2024v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Mar 10, 2024 to Jun 10, 2024v4
  2. Notable Start date: Dec 10, 2023 to Mar 10, 2024v3
  3. Notable Start date: Oct 10, 2023 to Dec 10, 2023v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Glofitamab is a class of medications called bispecific antibodies. Bispecific antibodies are designed to simultaneously bind to T cells and cancer cell antigens, leading to T-cell activation, proliferation, and cancer cell death. Giving acalabrutinib, obinutuzumab, and glofitamab together may be a safe and effective treatment for patients with relapsed or refractory mantle cell lymphoma.
Trial Details
NCT Number NCT06054776
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Mantle Cell Lymphoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov