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

AbbVie

Status and phase

Completed

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Navitoclax

Study type

Interventional

Funder types

Industry

Identifiers

M13-641

2012-000606-29 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.