{"groups":[{"description":"Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).\n\nRegimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen\n\nRegimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)","id":"FG000","title":"Low Risk - Treatment With 3 Cycles of R-CODOX-M"},{"description":"Patients are stratified between high risk and low risk disease status.\n\nHigh risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.\n\nRegimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen\n\nRegimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)","id":"FG001","title":"High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"5"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Treatment on Study"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"5"}],"comment":"All patients that receive one dose of study drug go into the follow-up phase.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"5"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Follow up for 2 Years"}],"preAssignmentDetails":"Patients were stratified as either high-risk or low-risk.\n\nLow Risk= patients with normal Lactic acid dehydrogenase (LDH) level, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, Ann Arbor stage as I or II and no tumor mass over 10 cm in greatest diameter.\n\nHigh Risk = All other patients","recruitmentDetails":"The study opened for accrual on October 4, 2006 with the first patient enrolling and starting treatment on February 6, 2007 and an accrual goal of up to 25 patients. The study was closed permanently on April 26, 2011 to further accrual with 25 patients enrolled on the study."}