An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
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).
Inclusion Criteria:
- The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for
any reason prior to study closure and the investigator believes that continued
treatment with navitoclax is in the best interest of the subject
- The subject must meet defined hematology and coagulation lab criteria as specified in
the protocol
- The subject must meet defined chemistry criteria as specified in the protocol
- Women of childbearing potential and men must agree to use adequate contraception (as
per protocol) prior to study entry, for the duration of study participation and up to
90 days following completion of therapy
- The subject is capable of understanding and complying with parameters as outlined in
the protocol and able to sign the Informed Consent Form
Exclusion Criteria:
- The subject discontinued navitoclax administration in Arm C of the ABT4710n study for
reasons of disease progression, Adverse Event toxicity, withdrawal of consent or
Investigator decision prior to study completion.
- The subject has any medical condition which in the opinion of the investigator places
the subject at an unacceptably high risk for toxicities.
- The subject is a lactating or pregnant female.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.
Outcome Description:
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.
Outcome Time Frame:
Adverse events occuring through the Final Visit (up to Week 52) will be reported
Safety Issue:
Yes
Principal Investigator
Mack Mabry, MD
Investigator Role:
Study Director
Investigator Affiliation:
AbbVie
Authority:
United States: Food and Drug Administration
Study ID:
M13-641
NCT ID:
NCT01557777
Start Date:
June 2012
Completion Date:
July 2013
Related Keywords:
- Chronic Lymphocytic Leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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 |
