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Study identifier: NCT05010122 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Condition: Acute Myeloid Leukemia · Myelodysplastic Syndrome · Recurrent Acute Myeloid Leukemia  ·  Sponsor: M.D. Anderson Cancer Center

PhasePhase 1/Phase 2
Planned participants42
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase I/II trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.

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

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Contact details are listed per location below or on the registry record.

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Locations (1)

M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05010122