Spots Global Cancer Trial Database for Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma
Official Title: A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of Non-Hodgkin's Lymphoma
Study ID: NCT00614042
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
For additional information regarding sites for this trial call 919-319-9374, Birmingham, Alabama, United States
For additional information regarding sites for this trial call 919-319-9374, Augusta, Georgia, United States
For additional information regarding sites for this trial call 919-319-9374, Boston, Massachusetts, United States
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
Contact Details
Name: Scott Stromatt, MD
Affiliation: Aptevo Therapeutics
Role: STUDY_DIRECTOR
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