Ruxolitinib and Venetoclax in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To evaluate the maximum-tolerated dose (MTD) and assess the safety of ruxolitinib in combination with venetoclax. SECONDARY OBJECTIVES: I. To assess the preliminary efficacy of the ruxolitinib and venetoclax combination. II. To estimate overall and event-free survival. EXPLORAT...

PRIMARY OBJECTIVE: I. To evaluate the maximum-tolerated dose (MTD) and assess the safety of ruxolitinib in combination with venetoclax. SECONDARY OBJECTIVES: I. To assess the preliminary efficacy of the ruxolitinib and venetoclax combination. II. To estimate overall and event-free survival. EXPLORATORY OBJECTIVES: I. To assess in vitro kinase inhibitor sensitivity using patient bone marrow (or peripheral blood) before and after treatment with the ruxolitinib and venetoclax combination. II. To use molecular techniques (potentially including next-generation sequencing and/or BH3 profiling) to examine the mechanisms of response versus (vs.) no response. III. To correlate molecular features with the patient response and resistance to venetoclax combination therapies. OUTLINE: This is a dose-escalation study of ruxolitinib. Patients receive ruxolitinib orally (PO) twice daily (BID) and venetoclax PO once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of ruxolitinib and venetoclax at the discretion of the sponsor-investigator. After completion of study treatment, patients are followed up every 6 months.

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