{"groups":[{"description":"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.","id":"FG000","title":"IBR+OB"},{"description":"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.","id":"FG001","title":"CLB+OB"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"21"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other, Not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"116"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"86"}],"comment":"On-study until study termination by sponsor.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"30"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Eligible participants were required to have had a diagnosis of active CLL/SLL conformant to IWCLL 2008 criteria. All subjects were required to have measurable nodal disease. Key exclusion criteria included any previous CLL/SLL treatment; known lymphoma or leukemia of the central nervous system, history/current evidence of Richter's transformation.","recruitmentDetails":"This study was conducted in 71 sites: 8 in the US, 36 in the EU, and 27 sites in 6 additional countries (Canada, Australia, New Zealand, Russia, Israel, Turkey). The first participant consented 06 October 2014. The last visit of the last participant was 03 September 2019, with a final database lock of 17 October 2019."}