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Study identifier: NCT06222580 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Condition: Acute Myeloid Leukemia With FLT3/ITD Mutation · Acute Myeloid Leukemia With KMT2A Rearrangement · Acute Myeloid Leukemia With NPM1 Mutation  ·  Sponsor: Uma Borate

PhasePhase 1
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia.

This description comes directly from the study's public registry record.

Talk to the study team

The Ohio State University Comprehensive Cancer Center  ·  800-293-5066  ·  OSUCCCClinicaltrials@osumc.edu

Always discuss trial participation with your own doctor first.

Locations (4)

UNC Hospitals, University of North Carolina at Chapel HillChapel Hill, North Carolina, United StatesRecruiting
Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United StatesRecruiting
University of PennsylvaniaPhiladelphia, Pennsylvania, United StatesRecruiting
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06222580