Eligibility for pre-selected salvage chemotherapy, according to the Investigator's assessment.Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood (allelic ratio as determined by a central laboratory with a cutoff of ≥3% FLT3 ITD/total FLT3).Induction therapy must have included at least 1 cycle of an anthracycline/mitoxantrone-containing induction block at a standard dose.
In first relapse (with duration of remission of 6 months or less) or refractory after prior therapy, with or without HSCT.Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.Age ≥18 years at the time of informed consent.Provision of written informed consent approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) with privacy language in accordance with national regulations (e.g., Health Insurance Portability and Accountability Act (HIPAA)) authorization for United States (US) sites prior to any study related procedures, including withdrawal of prohibited medications if applicable.Recruitment Status, Study Status, Contacts/Locations and Study Design Sponsor/Collaborators, Study Status and Study IdentificationĬontacts/Locations, Study Status and EligibilityĬontacts/Locations, Outcome Measures, Study Status, Eligibility and Arms and Interventions Study Status, Contacts/Locations and Eligibility Recruitment Status, Study Status, Contacts/Locations, Eligibility and Oversight