This phase I/II trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, 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. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
Diagnosis of 1) AML (World Health Organization [WHO] classification definition of >= 20% blasts) excluding acute promyelocytic leukemia (APL) or 2) MDS with > 10% blasts (defined by the International Prognostic Scoring System [IPSS] classification).
For frontline Cohort: Patients aged >= 60 years old who are not candidates for intensive induction therapy and agree to receive the proposed combination therapy will be enrolled.
75 years of age OR
Poor performance status (Eastern Cooperative Oncology Group [ECOG]) score of 2-3.
Patients with known allergy or hypersensitivity to quizartinib, mannitol, decitabine or any of their components.
Prior quizartinib use.
Patients with known uncontrolled CNS leukemia.
Only for frontline cohort: patients who are fit for intensive chemotherapy.
Single group
Decitabine
DrugGiven IV
Quizartinib
DrugGiven PO
Venetoclax
DrugGiven PO
Maximum tolerated dose of the combination drugs (Phase I)
Incidence of adverse events (Phase II)
Overall response rate (ORR) including CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) + partial remission (PR) (Phase II)
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Daiichi Sankyo
Collaborator
