{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"40"},{"groupId":"BG004","value":"55"}],"units":"Participants"}],"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":"BG000","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":"BG001","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":"BG002","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":"BG003","title":"Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)"},{"description":"Total of all reporting groups","id":"BG004","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"57","upperLimit":"82","value":"70.0"},{"groupId":"BG001","lowerLimit":"25","upperLimit":"74","value":"54.0"},{"groupId":"BG002","lowerLimit":"58","upperLimit":"75","value":"67.6"},{"groupId":"BG003","lowerLimit":"25","upperLimit":"76","value":"61.8"},{"groupId":"BG004","lowerLimit":"25","upperLimit":"82","value":"61.8"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"30"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"25"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"2"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"31"},{"groupId":"BG004","value":"42"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"5"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}]}