Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of Pevonedistat (TAK-924) and Decitabine Combination Therapy in High Risk Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of pevonedistat when given together with decitabine in treating patients with high risk acute myeloid leukemia. Pevonedistat and decitabine may stop the growth of cancer cells by blocking some of the enzymes need for cell growth.
PRIMARY OBJECTIVES: I. Determine if the addition of pevonedistat to standard dose decitabine is safe and tolerable by the evaluation of toxicities including: type, frequency, severity, attribution, time course, reversibility and duration. II. Determine the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) of pevonedistat when given in combination with standard dose decitabine. SECONDARY OBJECTIVES: I. Obtain preliminary estimates of complete remission (CR) rate, overall response rate (ORR: CR+CRi [incomplete CR]), duration of response, and survival probabilities: overall survival (OS) and event-free survival (EFS) at 1-year and 2-years. II. Demonstrate down-modulation of micro ribonucleic acid (miR)-155 and increased expression of miR-155 targets (SHIP1 and PU.1) in vivo. III. Examine the impact of the combination on leukemia stem cells (LSCs); enriched blast cell subpopulations. IV. Evaluate possible associations between changes in levels of miR-155, miR-155 gene targets (PU.1, SHIP1) and toxicity and/or clinical response. OUTLINE: This is a dose-escalation study of pevonedistat. Patients receive pevonedistat intravenously (IV) over 1 hour on days 1, 3, and 5 and decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unexpected toxicity. After completion of study treatment, patients are follow up for 30 days, monthly for 1 year, and bi-monthly for another year. ;
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