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

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT01557777

Run by

AbbVie (prior sponsor, Abbott)

People needed

17

Starts

2012-06-01

Expected to finish

2013-07-01

Last updated by the study team

2014-07-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 74036 — La Jolla, California, United States
• Site Reference ID/Investigator# 74035 — Los Angeles, California, United States
• Site Reference ID/Investigator# 74038 — Pleasant Hill, California, United States
• Site Reference ID/Investigator# 74039 — Santa Maria, California, United States
• Site Reference ID/Investigator# 74033 — Bethesda, Maryland, United States
• Site Reference ID/Investigator# 79201 — Coburg, Australia
• Site Reference ID/Investigator# 78993 — Greenslopes, Australia
• Site Reference ID/Investigator# 77860 — Afula, Israel
• Site Reference ID/Investigator# 77637 — Rehovot, Israel
• Site Reference ID/Investigator# 77413 — Gdansk, Poland
• Site Reference ID/Investigator# 79203 — Ivano-Frankivsk, Ukraine
• Site Reference ID/Investigator# 79205 — Khmelnitsky, Ukraine
• Site Reference ID/Investigator# 79202 — Kyiv, Ukraine
• Site Reference ID/Investigator# 79204 — Lviv, Ukraine
• Site Reference ID/Investigator# 79206 — Poltava, Ukraine

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.