{"groups":[{"description":"Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive SOC therapy for an additional 12 months.","id":"FG000","title":"Standard of Care Chemotherapy"},{"description":"Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.\n\nParticipants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.\n\nThe initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.","id":"FG001","title":"Blinatumomab"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"160"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"271"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"267"}],"type":"Received Treatment"},{"achievements":[{"comment":"Indicates participants continuing study at time of data cut-off","groupId":"FG000","numSubjects":"33"},{"comment":"Indicates participants continuing study at time of data cut-off; 22 were receiving treatment","groupId":"FG001","numSubjects":"93"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"178"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in a 2:1 ratio to either blinatumomab or standard of care (SOC) chemotherapy regimens. Randomization was stratified by age (\\< 35 years vs ≥ 35 years), prior salvage therapy (yes vs no), and prior allogeneic hematopoietic stem cell transplantation (HSCT) (yes vs no) as assessed at the time of consent.","recruitmentDetails":"This study was conducted at 101 centers in 21 countries in Asia, Australia, Europe, and Latin and North America.\n\nThe first participant was enrolled on 03 January 2014 and treated on 06 January 2014. The last participant enrolled on 25 September 2015 and the data cutoff date for this report was 04 January 2016."}