Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Inclusion Criteria

• •Has provided written informed consent for participation in the study
• •Is aged 18 to 70 years at the time of enrollment into the study
• •Has newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008 classification (at Screening)
• •Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at enrollment
• •Has all of the required laboratory test results performed within 14 days prior to enrollment in the study.
• •Is capable of orally taking quizartinib
• •Is capable of being admitted to the hospital during the dose limiting toxicity (DLT) evaluation period
• •If a woman of childbearing potential, has a negative serum pregnancy test upon entry into this study and is willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
• •If male, is surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
• •7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to enrollment in the study
• •8. History of heart failure according to New York Heart Association (NYHA) Functional Classification: Class 3 or 4 heart failure
• •9. Left ventricular ejection fraction (LVEF) of ≤ 45% or lower than the institutional lower limit of normal value per multi-gated acquisition scan (MUGA) or echocardiogram done within 30 days prior to enrollment
• •10. Complete left bundle branch block
• •Has active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial, or antiviral therapy
• •Has active clinically relevant liver disease (such as active hepatitis B or active hepatitis C).
• •Has a history of human immunodeficiency virus (HIV). Patients will be tested for HIV prior to enrollment in the study, if required by local regulations or the Ethics Committee.
• •Has a history of hypersensitivity to any excipients in the quizartinib tablets
• •Is a female who is pregnant or breastfeeding
• •Is considered inappropriate for the study by the investigator