The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.
This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
TRU-016 administered via IV infusion weekly for 8 weeks and then monthly
For additional information regarding sites for this trial call 919-319-9374
Birmingham, Alabama, United States
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Augusta, Georgia, United States
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Boston, Massachusetts, United States
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
Time frame: 4 weeks after treatment
Preliminary indication of response as defined by NCI 1996 criteria
Time frame: 3 months after treatment
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For additional information regarding sites for this trial call 919-319-9374
Las Vegas, Nevada, United States
For additional information regarding sites for this trial call 919-319-9374
Durham, North Carolina, United States
For additional information regarding sites for this trial call 919-319-9374
Portland, Oregon, United States
For additional information regarding sites for this trial call 919-319-9374
Seattle, Washington, United States