NCT06235801

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Gilteritinib	Given by PO
DRUG	Momelotinib	Given by PO

Timeline

• Start date: 2024-05-22
• Primary completion: 2027-10-01
• Completion: 2029-10-01
• First posted: 2024-02-01
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study