A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

Inclusion Criteria

[Phase 1 part]

• Subject is defined as having previously untreated de novo AML according to the World Health Organization (WHO) criteria (2008) within 28 days prior to study enrollment.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Subject must meet all of the following criteria in the laboratory test at screening:
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of ≤ 2.5 × institutional upper limit of normal (ULN)
• Total serum bilirubin level of ≤ 1.5 × institutional ULN
• Serum creatinine level of ≤ 1.5 × institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 mL/min
• Subject is suitable for oral administration of ASP2215.
• Female subject falls under the following:
• Of non-childbearing potential:
• ・Post-menopausal (defined as at least 1 year with no menses without a medical reason such as drug administration) at screening, or
• ・Documented surgically sterile or status post-hysterectomy (at least 1 month prior to screening)
• Of childbearing potential:
• ・Has a negative result for the pregnancy test at screening, and
• ・Agrees to use an appropriate contraception starting at screening and throughout the study period and for 60 days after the final study drug administration
• Female subject agrees not to breastfeed starting at screening and throughout the study period and for 60 days after the final study drug administration.
• Female subject agrees not to donate ova starting at screening and throughout the study period and for 60 days after the final study drug administration.
• Male subject and his female spouse/partner who is of childbearing potential agrees to use an appropriate contraception starting at screening and throughout the study period and for 120 days after the final study drug administration.
• Male subject agrees not to donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
• Subject agrees not to participate in another interventional study while on study treatment.
• Subject can be admitted during the induction period.

[Phase 2 part]

• Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) according to World Health Organization (WHO) classification (2017) documented within 28 days prior to enrollment.
• Subject is positive for FLT3-ITD and/or TKD mutation in bone marrow or whole blood as determined by the central lab. Registration by the local lab result is not acceptable.
• Subject has an ECOG performance status (PS) 0 to 1. Subject who has an ECOG PS 2 is eligible only if the primary disease related symptoms such as pneumonia and febrile neutropenia are the cause of PS score.
• Subject is suitable for oral administration of ASP2215.
• Female subject is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 180 days after final study treatment administration.
• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.
• Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
• Male subject and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 120 days after the final study drug administration.
• 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 with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the p