Fred Hutchinson Cancer Center
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.
OUTLINE: Patients receive acalabrutinib orally (PO) twice a day (BID) and venetoclax PO once daily (QD) on days 1-28. Patients receive acalabrutinib alone for the first three 28 day cycles. Venetoclax is added beginning with Cycle 4. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration and biopsy, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed-up every 12 weeks an…
Inclusion Criteria: * Men and women \>= 18 years of age. * Diagnosis of CLL or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria. * Active disease per IWCLL 2018 criteria that require treatment. At least one of the following: * 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 * Massive nodes (\> 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy * Progressive lymphocytosis w…
Given PO
Given PO
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Undergo CT
Undergo MRI
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