Venetoclax and Ibrutinib in Treating Participants With High-Risk Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Summary

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Description

PRIMARY OBJECTIVES: I. To estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) after receiving ibrutinib monotherapy for at least 12 months and who have high risk CLL. SECONDARY OBJECTIVES: I...

PRIMARY OBJECTIVES: I. To estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) after receiving ibrutinib monotherapy for at least 12 months and who have high risk CLL. SECONDARY OBJECTIVES: I. Determine complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate after 6, 12, 18 and 24 cycles of combination therapy and to 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 MRD-negativity. III. Determine the safety of combined ibrutinib and venetoclax. IV. Determine the progression-free and overall survival. OUTLINE: Participants receive venetoclax orally (PO) once daily (QD) and ibrutinib PO QD. Courses repeat every 4 weeks for up to 24 courses in the absence of disease progression or unaccepted toxicity. After completion of study treatment, participants are followed up every 6-12 months.

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