{"groups":[{"description":"Arm A- Acalabrutinib 100 mg BID- Overall Study Period","id":"FG000","title":"Arm A- Acala 100 mg BID- Overall Study Period"},{"description":"IR or BR data not presented separately similar to combined treatment arms approved for D8223C00009","id":"FG001","title":"Arm B: Investigator Choice (IR or BR)-Main Study Period"},{"description":"Arm B- Investigator Choice of IR Crossed Over to Arm A- Acala. 100 mg BID","id":"FG002","title":"Arm B- Inv Choice of IR Crossed Over to Arm A- Acala. 100 mg BID"},{"description":"Arm B- Investigator Choice of BR Crossed Over to Arm A- Acala. 100 mg BID","id":"FG003","title":"Arm B- Inv. Choice of BR Crossed Over to Arm A- Acala. 100 mg BID"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"80"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Arm B Crossed Over to Arm A Acala 100 mg Monotherapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"155"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"119"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Arm B Treatment= Idelalisib Plus Rituximab"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"36"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Arm B Treatment = Bendamustine Plus Rituximab"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"This subject received 1st dose of study drug on 11Nov2011, completed study treatment on 14MAR2019, never crossed over, and and died 11 months after completing study treatment on 15Feb2020.","groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Completed study treatment at final DCO (03Sep2021)","type":"Completed"},{"achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Patients ongoing treatment at final DCO (03Sep2021)","type":"Completed"},{"achievements":[{"comment":"All 99 subjects ongoing treatment at final DCO.","groupId":"FG000","numSubjects":"99"},{"comment":"26 subjects ongoing treatment + 1 subject completed study treatment and died 11 months after completing study treatment on 15Feb2020.","groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Patients Ongoing Treatment + Patients Completed Study Treatment at Final DCO (03Sep2021)","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"128"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall for Arm A & Main for Arm B"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"2"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"N/A. Note: No subjects stayed in Arm: Investigator's choice of IR/BR during cross-over period.","groupId":"FG001","numSubjects":"0"},{"comment":"Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.","groupId":"FG002","numSubjects":"63"},{"comment":"Note: There were a total of 80 subjects in Arm B crossing over to Arm A shown under the last row of Main Study Period. Among them 63 were randomized to Arm B: IR and 17 were randomized to BR.","groupId":"FG003","numSubjects":"17"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"14"}],"comment":"Ongoing Treatment at Final DCO (03Sep2021)","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"21"},{"groupId":"FG003","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"ArmB: Inv.Choice Crossed Over to Acala"}],"preAssignmentDetails":"310 patients were enrolled in this study and agreed to move forward in participating in the trial.","recruitmentDetails":"A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia. A total of 310 subjects met the eligibility criteria and were randomized to the acalabrutinib arm (N = 155) and IR/BR arm (N = 155).\n\nAll but 3 subjects (1 randomized to acalabrutinib and 2 randomized to IR/BR) received study treatment."}