A study evaluating the effects of navitoclax (ABT-263) in patients with relapsed or refractory chronic lymphocytic leukemia.

Phase 1

• Conditions: Relapsed or Refractory Chronic Lymphocytic Leukemia; MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864

• Registration Number: EUCTR2007-002143-25-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-27
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Chronic or relapsed Chronic Lymphocytic Leukemia and require treatment in the opinion of the investigator.
2. Eastern Cooperative Oncology Group (ECOG) performance score of = 1.
3. Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has a history or is significantly suspicious for cancer related Central Nervous System (CNS) disease.
2. Receipt of allogenic or autologous stem cell transplant.
3. Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently
exhibit signs of bleeding.
4. Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
5. Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year
of first dose).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified