Subject agrees not to participate in another interventional study for AML while on treatment. Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration. Male subject (even if surgically sterilized) and partners who are women of childbearing potential must agree to practice 2 forms of effective contraception per locally accepted standards (1 of which must be a barrier method), starting at screening and throughout the study period and for 120 days after the final study drug administration. Female subject must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration. Or, if of childbearing potential, - Agree not to try to become pregnant during the study and for at least 180 days after the final study drug administration - And have a negative urine pregnancy test at screening - And, if heterosexually active, agree to use consistently 2 forms of effective contraception per locally accepted standards (1 of which must be a barrier method) starting at screening and throughout the study period and for at least 180 days after the final study drug administration. Subject who has developed overall grades II-IV acute graft-versus-host disease (GVHD) must satisfy the following criteria: - No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1 week of enrollment - No escalation of immunosuppression in terms of increase of corticosteroids or addition of new agent/modality in prior 2 weeks (note that increasing calcineurin inhibitors or sirolimus to achieve therapeutic trough levels is allowed) - Female subject must either: - Be of nonchildbearing potential: - Postmenopausal (defined as at least 1 year without any menses) prior to screening, or - Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 1 month prior to screening. Subject is able to tolerate oral administration of study drug. Subject must meet the following criteria as indicated on clinical laboratory tests: - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x institutional upper limit of normal (ULN) - Serum total bilirubin ≤ 2.5 mg/dL, except for subjects with Gilbert's syndrome - Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN). Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting ASP2215. Subject has refractory or relapsed AML (with or without hematopoietic stem cell transplant ) or AML in CRc (CR, CRi, CRp) with MRD by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT. Subject has presence of the FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD in bone marrow or peripheral blood. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) or therapy-related AML according to World Health Organization (WHO) classification.
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Inclusion Criteria: - Subject is considered an adult according to local regulation at the time of signing informed consent.
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An end of treatment visit will be performed within 7 days after last dose of investigational product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up. Subjects will be provided with study medication until the investigator determines the subject is no longer receiving clinical benefit. Subjects will complete visits on cycle 1 - days 1, 4, 8, 15 cycle 2 - days 1, 15 cycles 3 to 6 - day 1 and day 1 of every 2 cycles thereafter (i.e., cycle 8 day 1, cycle 10 day 1, etc.) until discontinued from the study. This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in FLT3-mutated AML subjects. The United States Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and Health Canada have approved ASP2215/Gilteritinib (XOSPATA®) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.