{"groups":[{"description":"Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\\<60 years \\[yrs\\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\\^2 as 2-hour IV infusion (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.","id":"FG000","title":"Cohort A: Ponatinib 30 mg"},{"description":"Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\\^2 every 12 hours as a 2-hour-IV infusion (\\<60 yrs) and 250 mg/m\\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\\^2 (\\<60 yrs) and 250 mg/m\\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.","id":"FG001","title":"Cohort B: Imatinib 600 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"63"}],"type":"Participants Ongoing on Study"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"13"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"164"},{"groupId":"FG001","numSubjects":"81"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"154"},{"groupId":"FG001","numSubjects":"78"}],"comment":"Efficacy evaluable population was defined as all participants in the ITT population with BCR:ABL1 dominant variant of p190 or p210 confirmed by central lab.","type":"Efficacy Evaluable Population"},{"achievements":[{"groupId":"FG000","numSubjects":"163"},{"groupId":"FG001","numSubjects":"81"}],"comment":"The safety population was defined as all participants who were randomized to the ponatinib or imatinib arm and received at least 1 dose of any study drug.","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"164"},{"groupId":"FG001","numSubjects":"81"}],"type":"NOT COMPLETED"}],"title":"IP (Cycles 1-3) (Cycle Length=28 Days)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Participants are still ongoing in Induction Phase.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"CP (Cycles 4-9) (Cycle Length=28 Days)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Participants are still ongoing in Induction Phase.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"MP (Cycles 10-20) (Cycle Length=28 Days)"}],"preAssignmentDetails":"Participants with a diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) were enrolled in a 2:1 ratio to receive ponatinib or imatinib.","recruitmentDetails":"Participants took part in the study at 77 investigative sites in Australia, China, Korea, Taiwan, Austria, France, Greece, Italy, Poland, Russia, Spain, Turkey, United States, Canada, Mexico, Argentina and Brazil from 04 October 2018 to 31 July 2027. This study is ongoing. The data is reported for primary outcome measures up to 12 August 2022."}