87
Participants
Start Date
September 30, 2012
Primary Completion Date
February 24, 2020
Study Completion Date
April 21, 2021
20 mg/kg TRU-016 + Rituximab
"TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses~Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses"
10 mg/kg TRU-016 + Rituximab
"TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses~Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule"
TRU-016 20 mg/kg + Obinutuzumab
"TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months~Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months"
TRU-016 6-20 mg/kg + idelalisib + rituximab
TRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months.
TRU-016 10-20 mg/kg + ibrutinib
TRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg.
TRU-016 10-20 mg/kg + bendamustine
TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days). Bendamustine (90 mg/m2 on days 2 and 3 of cycle 1 and then days 1 and 2 of cycles 2 to 6) will be infused after completion of TRU-016. If a patient is benefiting with stable disease or better, then TRU-016 may continue to be dosed every 3 weeks after the first 6 cycles; bendamustine will not be dosed beyond 6 cycles.
University of Pittsburgh, Pittsburgh
Eastern Regional Medical Center, Philadelphia
Greenville Health System, Greenville
Augusta
Columbus
Houston
Swedish Cancer Institute,1221 Madison St., Seattle
Fred Hutchinson Cancer Research Center, Seattle
Lead Sponsor
Aptevo Therapeutics
INDUSTRY