{"groups":[{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"FG000","title":"Phase I Stage A Level 1"},{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"FG001","title":"Phase I Stage A Level 2"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"FG002","title":"Phase I Stage B Level 1"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"FG003","title":"Phase I Stage B Level 2"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"FG004","title":"Phase I Dose Expansion"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"FG005","title":"Phase II"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"12"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Symptomatic Deterioration"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"},{"comment":"Per protocol, a 10 patient expansion cohort is used to confirm the MTD determined in Stage B .","groupId":"FG004","numSubjects":"10"},{"groupId":"FG005","numSubjects":"23"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"comment":"The Phase I dose expansion cohort was not evaluated for cycle 1 dose-limiting toxicity.","groupId":"FG004","numSubjects":"0"},{"comment":"The Phase II cohort was not evaluated for cycle 1 dose-limiting toxicity.","groupId":"FG005","numSubjects":"0"}],"type":"Evaluable for Phase I Dose-Limiting Toxicity"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"comment":"Since treatment was not of fixed duration, all participants were considered as 'Not Completed' and reason off-treatment is provided.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"10"},{"groupId":"FG005","numSubjects":"23"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"Participants were enrolled from April 2010 to July 2013."}