MC198B, Phase II Study of a Combination Therapy of Acalabrutinib, Venetoclax and Durvalumab in Patients With Richter Transformation From Chronic Lymphocytic Leukemia (CLL)
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. Determine the progression free survival (PFS) at 6 months of the combination therapy of acalabrutinib, venetoclax, and durvalumab in patients with Richter transformation from chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. Determine the safety of the combination therapy of acalabrutinib, venetoclax and durvalumab in patients with Richter transformation from CLL. II. Evaluate the overall response rate (ORR), complete response (CR) rate, and partial response (PR) rate of the above combination therapy. III. Overall survival, PFS, and treatment free survival…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years willing to provide consent and follow-up * Diagnosis of CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria (Hallek et al., 2018) or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) 2008 criteria (Harris, 1999). This includes previous documentation of: * Biopsy-proven SLL according to WHO 2008 criteria, or * Diagnosis of CLL according to IWCLL 2018 criteria as evidenced by all of the following: * Peripheral blood B cell count of \>= 5 x 10\^9/L consisting of small to…
Interventions
- DrugAcalabrutinib
Given PO
- BiologicalDurvalumab
Given IV
- DrugVenetoclax
Given PO
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedurePositron Emission Tomography (PET)
Undergo PET/CT
Locations (3)
- Stanford Cancer Institute Palo AltoPalo Alto, California
- Mayo Clinic in RochesterRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri