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

• Status: Active, not recruiting
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie; AbbVie (prior sponsor, Abbott)
• Collaborator: Genentech, Inc.
• Treatments: Navitoclax

Criteria

Inclusion Criteria:

• Relapsed or refractory Chronic Lymphocytic Leukemia 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.

Exclusion Criteria:

• 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).