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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Adverse events occuring through the Final Visit (up to Week 52) will be reported

Safety Issue:

Yes

Principal Investigator

Mack Mabry, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M13-641

NCT ID:

NCT01557777

Start Date:

June 2012

Completion Date:

July 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Site Reference ID/Investigator# 74036La Jolla, California  92093
Site Reference ID/Investigator# 74035Los Angeles, California  90095-7059
Site Reference ID/Investigator# 74038Pleasant Hill, California  94523
Site Reference ID/Investigator# 74039Santa Maria, California  93454
Site Reference ID/Investigator# 74033Bethesda, Maryland  20817