17
Participants
Start Date
July 3, 2017
Primary Completion Date
October 1, 2024
Study Completion Date
October 1, 2027
Lenalidomide
Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.
Rituximab
During cycle 1, rituximab will be administered on day 4 prior to the start of etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH). During cycles 2 to 6, rituximab will be administered on day 1 of each cycle.
Prednisone
During cycle 1, Prednisone 60 mg/m\^2 /day by mouth (PO) days 6 to 10. During cycles 2-6, Prednisone 60 mg/m\^2 /day PO days 1-5.
Etoposide
During cycle 1, Etoposide 50 mg/m\^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide 50 mg/m\^2/day continuous intravenous infusion days 1 to 4.
Doxorubicin
During cycle 1, Doxorubicin 10 mg /m\^2/day continuous intravenous infusion days 6 to 9. During cycles 2-6, Doxorubicin continuous intravenous infusion days 1 to 4.
Vincristine
During cycle 1, Vincristine 0.4 mg/m\^2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Vincristine continuous intravenous infusion days 1 to 4.
Cyclophosphamide
During cycle 1, Cyclophosphamide 750 mg/m\^2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m\^2 day 5.
CT of neck, chest, abdomen and pelvis
Screening
18FDG-PET scan
Baseline
MRI Brain
Screening
Bone marrow biopsy
Baseline
EKG
Screening
Echocardiogram
Screening
Ultrasound
Day 6
Bronchoscopy
Baseline
Endoscopy
Baseline
CXR: PA/lat/decub
Screening
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH