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NCT Number: NCT01557777

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

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

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 79201, Coburg, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Navitoclax

Drug

QD

Other names: ABT-263

Primary outcomes

  1. Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.

    Time frame: 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.

  2. Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.

    Time frame: Change from baseline through Final Visit (up to Week 52).

    Physical exam, blood pressure, pulse, body temperature will be measured and recorded

  3. Safety: Clinical Lab Tests will be performed for each participant as a safety measure.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Jul 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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