Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1B/2A Trial of Combination of ASTX727 With ASTX029 in Acute Myeloid Leukemia
To find the recommended dose of the study drugs ASTX727 and ASTX029 that can be given to patients with relapsed/refractory AML. The goal of Part 2 of the study is to learn if the dose of study drugs found in Part 1B can help to control AML.
Primary Objectives: To determine the safety and recommended phase 2 dose (RP2D) of ASTX727 in combination with ASTX029 in patients with relapsed/refractory AML. Secondary Objectives: - To assess the CR+CRi+PR and MLFS rate within 6 cycles of treatment initiation of ASTX727 in combination with ASTX029 in patients with relapsed refractory AML. - To determine the duration of response (DOR), event-free survival (EFS), overall survival (OS), minimal/measurable residual disease (MRD) status at response and best MRD response attained by flow-cytometry, 4- and 8-week mortality - To investigate correlations of response to these combinations with a pre- therapy, on-therapy, and progression 81-gene panel of gene mutations in AML. Exploratory Objectives: - To investigate possible relationships between response and non-response to the combinations with myeloid mutation panel. - To identify leukemic subpopulations and how their signaling state in disease relates to clinical outcomes by Flow cytometry or CyTOF (mass cytometry) on patients' bone marrow samples and/or peripheral blood baseline, on treatment, remission and relapse and potentially other time-points on study. - To store and/or analyze surplus blood or tissue including bone marrow, if available, for potential future exploratory research into factors that may influence development of AML and/or response to the combination (where response is defined broadly to include efficacy, tolerability or safety). ;
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