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

NCT ID: NCT01557777

Last Updated: 2014-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Navitoclax, ABT-263

Group Type EXPERIMENTAL

Navitoclax

Intervention Type DRUG

QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Navitoclax

QD

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-263

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mack Mabry, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 74036

La Jolla, California, United States

Site Status

Site Reference ID/Investigator# 74035

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 74038

Pleasant Hill, California, United States

Site Status

Site Reference ID/Investigator# 74039

Santa Maria, California, United States

Site Status

Site Reference ID/Investigator# 74033

Bethesda, Maryland, United States

Site Status

Site Reference ID/Investigator# 79201

Coburg, , Australia

Site Status

Site Reference ID/Investigator# 78993

Greenslopes, , Australia

Site Status

Site Reference ID/Investigator# 77860

Afula, , Israel

Site Status

Site Reference ID/Investigator# 77637

Rehovot, , Israel

Site Status

Site Reference ID/Investigator# 77413

Gdansk, , Poland

Site Status

Site Reference ID/Investigator# 79203

Ivano-Frankivsk, , Ukraine

Site Status

Site Reference ID/Investigator# 79205

Khmelnitsky, , Ukraine

Site Status

Site Reference ID/Investigator# 79202

Kyiv, , Ukraine

Site Status

Site Reference ID/Investigator# 79204

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 79206

Poltava, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Israel Poland Ukraine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-000606-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-641

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.