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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Navitoclax

• Registration Number: NCT01557777
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-20
• Study Start: 2012-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Disposition First Submitted: 2014-07-02
• Disposition First Submitted QC: 2014-07-02
• Last Update Submitted: 2014-07-02
• Disposition First Posted: 2014-07-04
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navitoclax, ABT-263	Navitoclax	-

Primary Outcome Measures

Name	Time	Method
Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.	Change from baseline through Final Visit (up to Week 52).	Physical exam, blood pressure, pulse, body temperature will be measured and recorded
Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.	Adverse events occuring through the Final Visit (up to Week 52) will be reported	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.
Safety: Clinical Lab Tests will be performed for each participant as a safety measure.	Change from baseline through Final Visit (up to Week 52).	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.

Trial Locations

Locations (15)

Site Reference ID/Investigator# 77637; 🇮🇱 Rechovot, Israel

Site Reference ID/Investigator# 74036; 🇺🇸 La Jolla, California, United States

Site Reference ID/Investigator# 74033; 🇺🇸 Bethesda, Maryland, United States

Site Reference ID/Investigator# 74035; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 74039; 🇺🇸 Santa Maria, California, United States

Site Reference ID/Investigator# 79201; 🇦🇺 Coburg, Australia

Site Reference ID/Investigator# 78993; 🇦🇺 Greenslopes, Australia

Site Reference ID/Investigator# 77413; 🇵🇱 Gdansk, Poland

Site Reference ID/Investigator# 79203; 🇺🇦 Ivano-Frankivsk, Ukraine

Site Reference ID/Investigator# 79205; 🇺🇦 Khmelnitsky, Ukraine

Site Reference ID/Investigator# 79202; 🇺🇦 Kyiv, Ukraine

Site Reference ID/Investigator# 79204; 🇺🇦 Lviv, Ukraine

Site Reference ID/Investigator# 79206; 🇺🇦 Poltava, Ukraine

Site Reference ID/Investigator# 77860; 🇮🇱 Afula, Israel

Site Reference ID/Investigator# 74038; 🇺🇸 Pleasant Hill, California, United States