This phase II trial studies how well venetoclax and ibrutinib work in treating patients with
high-risk chronic lymphocytic leukemia. Drugs used in chemotherapy, 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. Ibrutinib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving
venetoclax and ibrutinib may work better in treating patients with chronic lymphocytic
I. To estimate the therapeutic efficacy of venetoclax consolidation in patients who have
detectable chronic lymphocytic leukemia (CLL) after receiving ibrutinib monotherapy for at
least 12 months and who have high risk CLL.
I. Determine complete remission (CR)/complete remission with incomplete hematologic recovery
(CRi) rate after 6, 12, 18 and 24 cycles of combination therapy in patients who were not in
CR/Cri at study initiation and estimate the time to best response with this combination.
II. Determine the cumulative rate of bone marrow minimal residual disease (MRD)-free complete
responders by an assay method with at least 0.01% sensitivity and median time to
III. Determine the safety of combined ibrutinib and venetoclax. IV. Determine the
progression-free and overall survival.
OUTLINE: This is a dose-escalation study of venetoclax.
Patients receive venetoclax orally (PO) once daily (QD) and ibrutinib PO QD. Treatment repeat
every 4 weeks for up to 24 cycles in the absence of disease progression or unaccepted
After completion of study treatment, patients are followed up every 6-12 months.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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