A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of 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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of TRU-016 administered IV in patients with CLL or NHL
4 weeks after treatment
No
Scott Stromatt, MD
Study Director
Emergent Product Development Seattle LLC
United States: Food and Drug Administration
16007
NCT00614042
January 2008
March 2012
Name | Location |
---|---|
For additional information regarding sites for this trial call 919-319-9374 | Birmingham, Alabama 35294 |
For additional information regarding sites for this trial call 919-319-9374 | Augusta, Georgia 30912 |
For additional information regarding sites for this trial call 919-319-9374 | Boston, Massachusetts 02111 |
For additional information regarding sites for this trial call 919-319-9374 | Las Vegas, Nevada 89135 |
For additional information regarding sites for this trial call 919-319-9374 | Durham, North Carolina 27710 |
For additional information regarding sites for this trial call 919-319-9374 | Portland, Oregon 97239 |
For additional information regarding sites for this trial call 919-319-9374 | Seattle, Washington 98109 |