Refractory Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study to Evaluate Safety of Ruxolitinib in Combination With Venetoclax in Patients With Relapsed/Refractory Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. This study is being done to see if the combination of ruxolitinib and venetoclax works better in treating patients with acute myeloid leukemia compared to standard of care chemotherapy.
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. IV. To determine the pharmacokinetic/pharmacodynamic (PK/PD) concentrations in vivo of the dual drug combination therapy. 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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