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Study identifier: NCT04140487 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Condition: Recurrent Acute Myeloid Leukemia · Recurrent Chronic Myelomonocytic Leukemia · Recurrent Myelodysplastic/Myeloproliferative Neoplasm  ·  Sponsor: M.D. Anderson Cancer Center

PhasePhase 1/Phase 2
Planned participants97
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as azacitidine, 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 azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome/myeloproliferative neoplasm.

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

Talk to the study team

Nicholas Short  ·  713-563-4485  ·  nshort@mdanderson.org

Always discuss trial participation with your own doctor first.

Locations (1)

M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04140487