Gilteritinib and Momelotinib for Relapsed or Refractory FLT3-Mutated AML

This study is testing a combination of two drugs, gilteritinib and momelotinib, for adults with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments. Your AML must have a specific genetic change called a FLT3 mutation to be eligible. The main goal of the study is to find the safest and most effective dose of momelotinib when given with gilteritinib. Researchers will also look at how well this combination works to reduce leukemia and improve survival. This is a small study, planning to enroll about 20 participants.

Study design
This is an interventional study, meaning you will receive a specific treatment. It is a Phase I/II study, which typically means it first looks at safety and then effectiveness, and plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06235801

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~20 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:GilteritinibMomelotinib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Myeloid Leukemia
1 sites across 1 states
Texas1
  • Nicholas Short, MD · PRINCIPAL_INVESTIGATOR · MD Anderson Center

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0