{"groups":[{"description":"Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).","id":"FG000","title":"Main Cohort: Single Dose of CTL019"},{"description":"Pediatric B-ALL patients who are very high risk at first relapse.","id":"FG001","title":"Cohort 1: Single Dose of CTL019"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"}],"type":"New therapy for study indication"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}],"type":"Subject/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"1"}],"comment":"Started = Enrolled in All cohorts","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"1"}],"type":"Enrolled and Infused"},{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"1"}],"type":"Discontinued Study Follow-up"},{"achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Completed = study follow-up completed","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"This study was conducted in 11 countries with 23 sites.","recruitmentDetails":"98 patients met the eligibility criteria and apheresis was accepted by the manufacturing facility, 80 patients were infused in this study: 79 in the Main Cohort and 1 in Cohort 1. No patients were infused in Cohort 2. Patients could discontinue the trial after meeting the eligibility criteria and prior to tisagenlecleucel infusion."}