NCT01644253

Phase 1b Safety and Efficacy Study of TRU-016

Phase 1b, Open Label Study to Evaluate Safety and Efficacy of TRU-016 in Combination With Rituximab, Obinutuzumab, Rituximab and Idelalisib, or Ibrutinib in Chronic Lymphocytic Leukemia and With Bendamustine in Peripheral T-cell Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Aptevo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of TRU-016 in combination with rituximab, in combination with obinutuzumab, in combination with rituximab and idelalisib, or in combination with ibrutinib in patients with CLL; and in combination with bendamustine in patients with PTCL.

Detailed description

The study will consist of 8 dose cohorts: 1. Previously untreated patients 20 mg/kg TRU-016 + rituximab. 2. Relapsed patients, 20 mg/kg TRU-016 + rituximab. 3. Previously untreated patients 10 mg/kg TRU-016 + rituximab. 4. Previously untreated patients TRU-016 + obinutuzumab. 5. Relapsed patients, 20 mg/kg TRU-016 + rituximab + idelalisib. 6. Patients with CLL on ibrutinib or another BTK inhibitor for a total of more than 1 year who have not had a complete response (CR) will continue receiving ibrutinib or another BTK inhibitor. 7. Patients with CLL on ibrutinib or another BTK inhibitor with stable disease and in whom the cysteine 481 mutant clone is present at a level \>1%, will continue receiving ibrutinib or the alternative BTK inhibitor. 8. Patients with relapsed or refractory PTCL will receive 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 for 2 days every cycle for 6 cycles.

Conditions

• Chronic Lymphocytic Leukemia
• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2020-02-24
• Completion: 2021-04-21
• First posted: 2012-07-19
• Last updated: 2021-05-20

Locations

8 sites across 1 country: United States