{"groups":[{"description":"One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\\^2/day intravenous \\[IV\\] on Days 1-6), vincrisitne (1.5 mg/m\\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\\^2 IV for 1 hour on Days 2-4), and pegylated \\[PEG\\]-asparaginase (1000 U/m\\^2 IV for 2 hours or intramuscularly \\[IM\\] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\\^2 IV or IM every 48 hours for a total of 6 doses).","id":"FG000","title":"HC3 Chemotherapy"},{"description":"One 4-week cycle of blinatumomab 15 μg/m\\^2/day as a continuous intravenous infusion (CIVI).","id":"FG001","title":"Blinatumomab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Decision by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"10"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"54"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"54"}],"type":"Participants Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"54"}],"comment":"Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (the full analysis set; FAS) at the primary completion date (17 July 2019)","type":"Participants in the Primary Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"54"}],"comment":"Included all randomized participants analyzed according to their randomized treatment assignment, regardless of treatment received (FAS) at study completion (21 November 2022)","type":"Participants in the Final Analysis Population"},{"achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"33"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"21"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"After a 3-week screening period, participants were enrolled and randomized 1:1 into 1 of 2 treatment groups: High Risk Consolidation 3 (HC3) chemotherapy or blinatumomab.\n\nRandomization was stratified by age and bone marrow/minimal residual disease (MRD) status.","recruitmentDetails":"This study was conducted at 48 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015. The last participant enrolled on 30 August 2019.\n\nThe primary completion date was 17 July 2019 and the study completion date was 21 November 2022."}