Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05388006 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-03-25
Summary
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.
Conditions
- Chronic Lymphocytic Leukemia
- Richter Syndrome
- Small Lymphocytic Lymphoma
Interventions
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
- DRUG
-
Given PO
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Bone Marrow Aspiration
Undergo bone marrow aspiration
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- PROCEDURE
-
Positron Emission Tomography (PET)
Undergo PET/CT
- PROCEDURE
-
Computed Tomography
Undergo PET/CT or CT
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Paul J. Hampel, MD · Mayo Clinic in Rochester
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-05
- Primary Completion
- 2027-02-22
- Completion
- 2027-02-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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