A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

Key facts

Study ID

NCT00481091

Run by

AbbVie

People needed

60

Starts

2007-07-25

Expected to finish

2022-05-12

Last updated by the study team

2023-06-13

Who can join

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

You may qualify if…

• Relapsed or refractory CLL and require treatment in opinion of investigator.
• Eastern Cooperative Oncology Group (ECOG) <= 1.
• Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

You may not qualify if…

• History or is clinically suspicious for cancer-related Central Nervous System disease.
• Receipt of allogenic or autologous stem cell transplant.
• Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
• Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
• Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

Where it is running

• Moores Cancer Center at UC San Diego /ID# 5566 — La Jolla, California, United States
• Dana-Farber Cancer Institute /ID# 5547 — Boston, Massachusetts, United States
• University of Nebraska Medical Center /ID# 12261 — Omaha, Nebraska, United States
• North Shore University Hospital /ID# 12267 — New Hyde Park, New York, United States
• University of Texas MD Anderson Cancer Center /ID# 5575 — Houston, Texas, United States
• Northwest Medical Specialties - Tacoma /ID# 26428 — Tacoma, Washington, United States
• Peter MacCallum Cancer Ctr /ID# 6583 — Melbourne, Victoria, Australia
• The Royal Melbourne Hospital /ID# 5576 — Parkville, Victoria, Australia
• Universitaetsklinikum Koeln /ID# 5924 — Cologne, North Rhine-Westphalia, Germany
• Leicester Royal Infirmary /ID# 15081 — Leicester, England, United Kingdom

Full record on ClinicalTrials.gov

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