Acute Myelogenous Leukemia Clinical Trial
Official title:
A Multisite Phase Ib Study of Pevonedistat, Azacitidine (or Decitabine), and Venetoclax (PAVE) for the Treatment of Patients With Acute Myelogenous Leukemia (AML)
This is a phase Ib study with a 3 + 3 dose escalation design followed by a dose-expansion phase.
The study hypothesis is that the combination of pevonedistat, azacitidine, and venetoclax will be effective, safe, and well tolerated in patients with AML. The primary objective of this portion of the study is to determine a recommended phase 2 dose (RP2D) of pevonedistat, azacitidine, and venetoclax. The investigators will use a variation of the 3+3 design where both escalation and de-escalation are possible. A minimum of nine and a maximum of 24 subjects will be needed for the phase 1 part of the study (dose-escalation phase). The dose limiting toxicity (DLT) observation period for dose escalation will be during cycle 1. Prior to enrolling patients at the next applicable dose level, all patients must complete the DLT period of the current dose level. The Data Safety Monitoring Committee will review the results of each dose level before the next applicable dose level opens for enrollment. Dose Expansion Phase The primary objective of this portion of the study is to confirm the feasibility and tolerance of the combination of pevonedistat, azacitidine, and venetoclax in patients with AML. Given that the dose-escalation phase described above will be able to establish the RP2D, the dose-expansion phase will employ this dose. In addition to relapsed/refractory AML patients, newly diagnosed AML patients can also be included in this phase to assess the feasibility and tolerance of this combination regimen. A minimum of six patients will be enrolled in the dose-expansion phase, which could be expanded based on the safety and tolerability. ;
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