RecruitingPhase I/IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Rozpoznana białaczka szpikowa z mutacją FLT3 (nowa, nawrotowa lub oporna na leczenie)
  • Lub zespół mielodysplastyczny wysokiego ryzyka z mutacją FLT3
  • Pacjenci, którzy nie mogą otrzymać chemioterapii standardowej (np. ze względu na wiek powyżej 75 lat lub choroby serca/płuc)
  • Możliwość połykania
  • Prawidłowa funkcja wątroby i nerek

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

M D Anderson Cancer Center

Houston, United States

Trial contact

Farhad Ravandi-Kashani

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.

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