Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
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 to allogeneic hematopoietic stem cell transplantation - To determine the safety of the combination regimen Exploratory Objectives - To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen - To determine the impact of baseline FLT3 allelic ratio on response and survival - To evaluate the pharmacokinetics (e.g. AUC, Cmax, Tmax and half-life) of momelotinib in the combination regimen - To evaluate changes in circulating cytokine levels in response to treatment - To evaluate inhibition of FLT3 signaling and inhibition of JAK/STAT signaling pathways - To evaluate other biomarkers associated with response and resistance to the combination regimen ;
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