A Phase 2 Study of Acalabrutinib, Venetoclax and Tafasitamab (AVT) in Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
City of Hope Medical Center
Summary
This phase II trial tests the safety, side effects and how well giving tafasitamab with acalabrutinib and venetoclax works for the treatment of chronic lymphocytic leukemia (CLL)/small cell lymphoma (SLL). 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). Tafasitamab is a monoclonal antibody that binds to CD19 antigen which is found on the surface of most B cells (a type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. 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 mantle cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. 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. Giving tafasitamab with acalabrutinib and venetoclax may be safe and effective for treating patients with CLL/SLL.
Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of tafasitamab in combination with acalabrutinib and venetoclax, as assessed by unacceptable toxicity, in patients with previously untreated CLL/SLL. (Safety lead-in) II. To evaluate efficacy of tafasitamab in combination with acalabrutinib and venetoclax, as assessed by complete response (CR) with undetectable minimal residual disease (MRD) by flow cytometry in peripheral blood, in patients with previously untreated CLL/SLL. (Phase 2) SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of tafasitamab in combination…