Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

Study Overview
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Brief Summary
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Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Detailed Description
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This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Official Title
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An Extension Study of Navitoclax (ABT-263) in Subjects With Chronic Lymphocytic Leukemia (CLL)

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Navitoclax


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navitoclax, ABT-263<br> | Drug: Navitoclax<br>* QD<br>* Other names: ABT-263;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. | Physical exam, blood pressure, pulse, body temperature will be measured and recorded | Change from baseline through Final Visit (up to Week 52). | 
| Safety: Clinical Lab Tests will be performed for each participant as a safety measure. | Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution. | Change from baseline through Final Visit (up to Week 52). |