City of Hope Medical Center
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.
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…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically or flow cytometry confirmed diagnosis of B-CLL/SLL as documented by medical records and with histology based on criteria established by the World Health O…
Given PO
Undergo blood sample collection
Undergo bone marrow biopsy
Undergo CT scan
Undergo PET scan
Given IV
Given PO