{"groups":[{"description":"Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given.\n\nConsolidation: High-dose cytarabine and gilteritinib.\n\nGilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8\n\nConsolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)\n\nDaunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3\n\nSecond Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3\n\nCytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nSecond Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nConsolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles","id":"FG000","title":"Arm A"},{"description":"Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given.\n\nConsolidation: High-dose cytarabine and midostaurin.\n\nMidostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8\n\nConsolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)\n\nDaunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3\n\nSecond Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3\n\nCytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nSecond Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1\n\nConsolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles","id":"FG001","title":"Arm B"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"11"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"10"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"44"}],"type":"Intercurrent illness, Recurrence of disease, Subject proceeded to transplant or non-protocol therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"90"},{"groupId":"FG001","numSubjects":"87"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"81"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All randomized, eligible, and treated patients.\n\n3 patients passed away/withdrew before induction. 1 patient determined to not have the diagnosis to meet the eligibility criteria and was removed from the study (181 consented)."}