48
Participants
Start Date
January 28, 2015
Primary Completion Date
July 20, 2021
Study Completion Date
June 29, 2023
Carfilzomib
"Given IV, according to dose level. Cohorts begin with dose level (DL)1, escalated in standard 3+3 design to identify a recommended phase 2 dose DL (-2) 11 mg/m2 on day 1 and 2 every 21 days, cycles 1-6~DL (-1) 15 mg/m2 on days 1 and 2 every 21 days, cycles 1-6~DL (1) 20 mg/m2 days 1,2 every 21 days, cycles 1-6~DL (2) 20 mg/m2 days 1,2 of cycle 1 followed by 27 mg/m2 days 1,2 every 21 days for cycles 2-6.~DL (3) 20 mg/m2 days 1,2 of cycle 1 followed by 36 mg/m2 days 1,2 every 21 days for cycles 2-6.~DL(4) 20 mg/m2 days 1,2 of cycle 1 followed by 45 mg/m2 days 1,2 every 21 days for cycles 2-6~DL (5) 20 mg/m2 days 1,2 of cycle 1 followed by 56 mg/m2 days 1,2 every 21 days for cycles 2-6"
Rituximab
Given IV (375mg/m\^2)
Cyclophosphamide
Given IV (750mg/m\^2)
Doxorubicin hydrochloride
Given IV (50mg/m\^2)
Vincristine sulfate
Given IV (1.4mg/m\^2)
Prednisone
Given PO (100mg)
Pegfilgrastim
6 mg SC day 4 (every 21 days). Filgrastim 300 or 480 mcg IV/SC daily days 1-10 may be substituted if pegfilgrastim is not available. ONPROTM is also an acceptable method of administration.
Acyclovir
PO (400mg)
Roswell Park Comprehensive Cancer Center, Buffalo
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland
Case Comprehensive Cancer Center
OTHER