Phase 1b Safety and Efficacy Study of TRU-016

PHASE1TerminatedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

February 24, 2020

Study Completion Date

April 21, 2021

Conditions
Chronic Lymphocytic LeukemiaPeripheral T-cell Lymphoma
Interventions
BIOLOGICAL

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"

BIOLOGICAL

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"

BIOLOGICAL

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"

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (8)

15232

University of Pittsburgh, Pittsburgh

19124

Eastern Regional Medical Center, Philadelphia

29605

Greenville Health System, Greenville

30912

Augusta

43210

Columbus

77030

Houston

98104

Swedish Cancer Institute,1221 Madison St., Seattle

98109

Fred Hutchinson Cancer Research Center, Seattle

Sponsors
All Listed Sponsors
lead

Aptevo Therapeutics

INDUSTRY