Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion date changed from estimate of Feb 22, 2027 to Sep 23, 2026
    • Study completion pushed from Feb 22, 2027 to Mar 30, 2031
    • Study sites: 3 to 1
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. 2 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv11-v12
  3. Enrollment target: 30 to 27
    • Primary and study completion dates: Jan 15, 2027 to Feb 22, 2027
    • Site details revised at 1 of 3 sites
    v10
  4. Study sites: 1 to 3
    • Interventions: Acalabrutinib (Drug), Durvalumab (Biological), Venetoclax (Drug) to Acalabrutinib (Drug), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed…
    • Eligibility criteria expanded, about 100 words
    • Study description expanded, about 29 words
    v9
  5. Primary completion date: Nov 15, 2024 to Jan 15, 2027
    • Start date: Jun 15, 2022 to Jan 5, 2023
    • Study completion date: Nov 15, 2025 to Jan 15, 2027
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Enrollment target: 33 to 30
    • Site contact updated
    v7
  2. Re-verified, no change to tracked fieldsv6
  3. Site contact updatedv5
  4. Collaborators shortened, about 4 wordsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Start date: May 15, 2022 to Jun 15, 2022v2
  1. 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 tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib, venetoclax, and durvalumab may help improve survival in patients with Richter transformation.
Trial Details
NCT Number NCT05388006
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia, Richter Syndrome, Small Lymphocytic Lymphoma
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov