{"groups":[{"description":"Treatment:\n\nInduction:\n\n* Brentuximab vedotin 0.8 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks )\n* Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)\n\nConsolidation (optional): Identical to Induction.\n\nMaintenance: Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.","id":"FG000","title":"Brentuximab Vedotin Dose Level -1 (0.8 mg/kg)"},{"description":"Induction:\n\n* Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks\n* Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks)\n\nConsolidation (optional): Identical to Induction.\n\nMaintenance:\n\n* Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease.\n* Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.","id":"FG001","title":"Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"20"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"20"}],"type":"Received Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"20"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Induction (4 Weeks)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"Consolidation is optional for patients who have a partial or complete response during induction.","groupId":"FG001","numSubjects":"6"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"Received Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Consolidation (Optional, 4 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"Consolidation is optional for patients who have a partial or complete response during induction","groupId":"FG001","numSubjects":"20"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}],"type":"Received Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"1st Cycle of Maintenance (3 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}],"type":"Received Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"comment":"Completion = up to 1 year of maint. treatment from time of induction (1 maint. cycle = 3 weeks).","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"2nd Cycle of Maintenance and Beyond"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"Patients who received at least one dose of study treatment go into follow-up.","groupId":"FG001","numSubjects":"20"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"14"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Follow Up (up to 3 Years)"}],"recruitmentDetails":"The study opened for accrual on March 4th, 2013 with goal of up to 33 patients. The 1st patient started treatment in Phase 1 on March 5th, 2013. 6 patients were accrued in Phase 1. March 26th, 2014 the study opened to Phase II, 14 patients were accrued. October 29th, 2018 the study closed due to lack of funding."}