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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01644253.
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.
Lead OrganizationAptevo Therapeutics
