{"groups":[{"description":"All Patients for Induction (not assigned).","id":"FG000","title":"Induction (All Patients)"},{"description":"Eligible patients with MLL-G (germline, or non-rearranged)\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV","id":"FG001","title":"Arm A (Standard Risk MLL-G)"},{"description":"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV","id":"FG002","title":"Arm B (IR/HR MLL-R Chemotherapy)"},{"description":"Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 1 (DL1) (HR: 3.5 mg/kg/day; SR: 4 mg/kg/day)","id":"FG003","title":"Arm C (Safety/ Dose Level 1)"},{"description":"Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2) (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)","id":"FG004","title":"ARM C (Safety/ Dose Level 2)"},{"description":"Arm C, IR/HR MLL-R chemotherapy and lestaurtinib at Dose Level 2 (DL2)-Efficacy (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)","id":"FG005","title":"Arm C (Efficacy/ Dose Level 2)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Refusal of Further Protocol Therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Ineligible"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Inevaluable for post Induction"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Unable to receive Lestaurtinib-Not in US"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"218"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"192"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Induction"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"3"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"5"}],"type":"Refusal of Further Protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"20"}],"type":"Relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Developed second malignant neoplasm"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Patient Moved to Another Institution"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"5"}],"type":"Induction Failure"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"60"},{"groupId":"FG002","numSubjects":"54"},{"groupId":"FG003","numSubjects":"11"},{"groupId":"FG004","numSubjects":"11"},{"groupId":"FG005","numSubjects":"56"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"50"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"19"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"32"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"7"},{"groupId":"FG005","numSubjects":"37"}],"type":"NOT COMPLETED"}],"title":"Post Induction Therapy by Tx Assignment"}],"preAssignmentDetails":"MLL-germline \\[G\\] to SR (Arm A/Group 1), MLL-rearranged \\[R\\] randomized/assigned to Arm B (Group2; chemo) or Arm C (Group3; chemo+lestaurtinib) with dose determined by age at dx (\\>=90 days is IR and \\<90 days is HR)","recruitmentDetails":"Infants with Acute Lymphoblastic Leukemia (ALL)"}