{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"}],"units":"Participants"}],"description":"Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management","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)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One patient in cohort 2 was non-evaluable for dose-limiting toxicity.","reportingStatus":"POSTED","timeFrame":"Up to 21 days","title":"Dose-limiting Toxicity (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}