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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":"BG000","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":"BG001","title":"Arm B"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"13","value":"50"},{"groupId":"BG001","spread":"12","value":"51"},{"groupId":"BG002","spread":"13","value":"51"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"103"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"74"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"15"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"152"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"15"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"137"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"19"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"44"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"114"}],"title":"1"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"15"}],"title":"2"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}],"title":"3"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Unknown"}]}],"description":"0: Fully active, able to carry on all pre-disease performance without restriction.\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light house work, office work.\n2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours\n4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG (Eastern Cooperative Oncology Group) Performance Score","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"11"}],"title":"AML with Myelodysplasia-Related Changes"},{"measurements":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"79"},{"groupId":"BG002","value":"159"}],"title":"De Novo AML"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}],"title":"Therapy-Related AML"}]}],"description":"De Novo AML: AML that develops spontaneously without prior blood disorders or cancer treatments. Often associated with a comparatively better prognosis\n\nTherapy-Related AML (t-AML): AML that arises as a result of previous chemotherapy or radiation therapy. Generally considered a higher-risk category\n\nAML with Myelodysplasia-Related Changes (AML-MRC): AML that originates from or shows features of prior myelodysplastic syndromes or dysplasia. Also associated with a worse prognosis compared to De Novo AML","paramType":"COUNT_OF_PARTICIPANTS","title":"AML Category","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"AML related to previous chemotherapy or radiation"},{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"68"}],"title":"AML with certain genetic abnormalities"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"7"}],"title":"AML with myelodysplasia-related changes"},{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"100"}],"title":"AML not otherwise specified"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"WHO Classification","unitOfMeasure":"Participants"}]}