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

• Conditions: Chronic Lymphocytic Leukemia; MedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000606-29-PL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-16
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

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 ICF
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

• The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, AE toxicity, withdrawal of consent or PI 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Ongoing throughout study.;Main Objective: The primary objective is to assess the safety of navitoclax.;Secondary Objective: Not Applicable.;Primary end point(s): Safety of Navitoclax

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable.;Timepoint(s) of evaluation of this end point: Not Applicable.