{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.2","upperLimit":"100","value":"100"},{"groupId":"OG001","lowerLimit":"33.4","upperLimit":"97.9","value":"85.7"},{"groupId":"OG002","lowerLimit":"47.8","upperLimit":"100","value":"100"},{"groupId":"OG003","lowerLimit":"75.5","upperLimit":"96.1","value":"90.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"40"}],"units":"Participants"}],"description":"Percentage of patients alive and progression-free at 18 weeks.","dispersionType":"95% Confidence Interval","groups":[{"description":"Phase I Cohort 1:\n\nINDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.\n\nlenalidomide: Given PO\n\netoposide: Given IV\n\nprednisone: Given PO\n\nvincristine sulfate: Given IV\n\ndoxorubicin hydrochloride: Given IV\n\ncyclophosphamide: Given IV\n\nrituximab: Given IV","id":"OG000","title":"Treatment (Lenalidomide 10 mg, DA-EPOCH-R)"},{"description":"Phase I Cohort 2:\n\nINDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.\n\nlenalidomide: Given PO\n\netoposide: Given IV\n\nprednisone: Given PO\n\nvincristine sulfate: Given IV\n\ndoxorubicin hydrochloride: Given IV\n\ncyclophosphamide: Given IV\n\nrituximab: Given IV","id":"OG001","title":"Treatment (Lenalidomide 15 mg, DA-EPOCH-R)"},{"description":"Phase I Cohort 3:\n\nINDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.\n\nlenalidomide: Given PO\n\netoposide: Given IV\n\nprednisone: Given PO\n\nvincristine sulfate: Given IV\n\ndoxorubicin hydrochloride: Given IV\n\ncyclophosphamide: Given IV\n\nrituximab: Given IV","id":"OG002","title":"Treatment (Lenalidomide 20 mg, DA-EPOCH-R)"},{"description":"Phase II Cohort 4:\n\nINDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.\n\nlenalidomide: Given PO\n\netoposide: Given IV\n\nprednisone: Given PO\n\nvincristine sulfate: Given IV\n\ndoxorubicin hydrochloride: Given IV\n\ncyclophosphamide: Given IV\n\nrituximab: Given IV","id":"OG003","title":"Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"18 weeks","title":"Progression-free Survival at 18 Weeks","type":"SECONDARY","unitOfMeasure":"percentage of participants"}