Study of Azacitidine, Venetoclax, and Gilteritinib for Adults With FLT3-Mutated Acute Myeloid Leukemia or High-Risk MyelodysplasticMyeloproliferative Disorders

What this Trial Is About

Researchers are studying the combination of azacitidine, venetoclax, and gilteritinib in patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndromemyeloproliferative neoplasm that has returned or not responded to treatment. This phase III trial aims to find the best dose and evaluate how well the combination works compared to azacitidine and venetoclax alone. The study also explores genetic factors that may affect treatment response and survival. Participants receive azacitidine through injection under the skin or into a vein for 7 days, venetoclax orally daily for 28 days in the first cycle and for 21 days in later cycles, and gilteritinib orally daily for 28 days. Treatment cycles repeat every 28 days for up to 24 cycles, unless the disease progresses or side effects become unacceptable. The study has a dose-escalation phase to determine the maximum tolerated dose of gilteritinib, followed by a phase II treatment phase. During the study, patients are monitored through regular visits to assess response, side effects, and overall health. Researchers measure outcomes like complete remission rates, minimal residual disease, relapse-free survival, and overall survival over up to 3 years. After treatment ends, patients have follow-up visits at 30 days and every 6 months to continue assessing their condition and safety.

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