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
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 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Rozpoznana białaczka mieloidalna, przewlekła białaczka mielomonocytowa lub zaburzenia szpiku kostnego o średnim-wysokim lub wysokim ryzyku
- •Posiadanie mutacji FLT3 w komórkach nowotworowych
- •Zdiagnozowana choroba, która powróciła lub nie reaguje na dotychczasowe leczenie (dotyczy grupy fazy II B i fazy I)
- •Nowo rozpoznana białaczka mieloidalna z mutacją FLT3 (dotyczy grupy fazy II A)
- •Zadowalający stan ogólny umożliwiający uczestniczenie w badaniu
- •Prawidłowa funkcja nerek i wątroby
- •Zdolność do połykania tabletek
✗ Disqualifies
- •Wcześniejsze leczenie białaczki (dotyczy tylko pacjentów nowo rozpoznanych w grupie fazy II A)
- •Wrodzona arytmia serca typu wydłużony QT lub aktualnie wydłużony odstęp QT w elektrokardiogramie
- •Pacjenci zdolni do przyjęcia intensywnej chemioterapii (dla grupy fazy II A)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
M D Anderson Cancer Center
Houston, United States
Trial contact
Nicholas Short
Contact information from ClinicalTrials.gov. Contact in English.
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/7/2026.
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