M.D. Anderson Cancer Center
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
Primary Objectives * Phase I: To establish the minimum safe and biologically-effective dose of momelotinib in combination with gilteritinib in relapsed/refractory FLT3-mutated AML * Phase II: To determine the modified CRc rate of the regimen, including complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) Secondary Objectives * To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and FLT3 PCR, relapse-free survival, overall survival) * To assess proportion of participants proceeding t…
Inclusion Criteria: 1. Diagnosis: a) Adults ≥18 years with relapsed/refractory FLT3-mutated AML. Participants with either FLT3-ITD or FLT3 D835/D836 mutations will be eligible 2. Performance status ≤3 (ECOG Scale). 3. Adequate liver and renal function as defined by the following criteria: 1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI d) Cre…
Given by PO
Given by PO
Arctuva estimate
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