This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.
Men and women >= 18 years of age.
Diagnosis of CLL or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria.
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
Massive (> 6 cm below left costal margin), progressive, or symptomatic splenomegaly
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation (biopsy based on clinical suspicion may be needed to rule out transformation)
Prior disease progression while on a BTK inhibitor
Prior disease progression while on venetoclax
Prior intolerance to acalabrutinib or venetoclax
Fred Hutchinson Cancer Center
Lead sponsor
AstraZeneca
Collaborator