{"groups":[{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 in combination with R3 intravenously (IV) for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG000","title":"Phase 1b: Dose Escalation 1 (20 mg/m^2)"},{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 27 mg/m\\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG001","title":"Phase 1b: Dose Escalation 1 (20/27 mg/m^2)"},{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 27 mg/m\\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG002","title":"Phase 1b: Dose Escalation 2 (20/27 mg/m^2)"},{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 36 mg/m\\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG003","title":"Phase 1b: Dose Escalation 2 (20/36 mg/m^2)"},{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 45 mg/m\\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG004","title":"Phase 1b: Dose Escalation 2 (20/45 mg/m^2)"},{"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 56 mg/m\\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"FG005","title":"Phase 1b: Dose Escalation 2 (20/56 mg/m^2)"},{"description":"Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.","id":"FG006","title":"Phase 2: B-cell (20/56 mg/m^2)"},{"description":"Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.","id":"FG007","title":"Phase 2: T-cell (20/56 mg/m^2)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"41"},{"groupId":"FG007","numSubjects":"29"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"}],"type":"Withdrawal prior to Carfilzomib dosing"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"}],"type":"Decision by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"}],"type":"Protocol-specified criteria"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"10"},{"groupId":"FG006","numSubjects":"62"},{"groupId":"FG007","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"10"},{"groupId":"FG006","numSubjects":"61"},{"groupId":"FG007","numSubjects":"44"}],"type":"Received Carfilzomib During Induction Therapy"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"5"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"3"},{"groupId":"FG006","numSubjects":"25"},{"groupId":"FG007","numSubjects":"20"}],"type":"Received Carfilzomib During Consolidation Therapy"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"19"},{"groupId":"FG007","numSubjects":"13"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"43"},{"groupId":"FG007","numSubjects":"31"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Phase 1b: Participants underwent a 4-week induction and 4-week consolidation cycle, receiving two treatments. Phase 2: After a 7-day screening, participants received VXLD (vincristine, PEG-asparaginase, daunorubicin, dexamethasone) with carfilzomib during a 28-day induction. One B-cell group participant did not receive carfilzomib and was excluded from the primary analysis. Participants were followed for up to 2 years post-treatment.","recruitmentDetails":"Participants were recruited in Australia, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, France, Greece, Hong Kong, Italy, Israel, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, the UK and the US between February 2015 and June 2024."}