An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
This is an open-label extension study of navitoclax in subjects with chronic lymphocytic
leukemia (CLL).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution.
Adverse events occuring through the Final Visit (up to Week 52) will be reported
Yes
Mack Mabry, MD
Study Director
AbbVie
United States: Food and Drug Administration
M13-641
NCT01557777
June 2012
July 2013
Name | Location |
---|---|
Site Reference ID/Investigator# 74036 | La Jolla, California 92093 |
Site Reference ID/Investigator# 74035 | Los Angeles, California 90095-7059 |
Site Reference ID/Investigator# 74038 | Pleasant Hill, California 94523 |
Site Reference ID/Investigator# 74039 | Santa Maria, California 93454 |
Site Reference ID/Investigator# 74033 | Bethesda, Maryland 20817 |