Chronic Lymphocytic Leukemia Clinical Trial
Official title:
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
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.
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. ;
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