Spots Global Cancer Trial Database for A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Study Description

Brief Summary: To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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