HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Alemtuzumab; Fludarabine; Fludarabine phosphate; Ofatumumab

Criteria

Inclusion Criteria:

1. Tumor cell phenotype consistent with B-CLL

2. Patients with active B-CLL and with an indication for treatment

3. Failing at least one fludarabine-containing treatment regimen

4. Failing at least one alemtuzumab-containing treatment regimen

5. ECOG Performance Status of 0, 1, or 2

6. Life expectancy of at least 4 months

Exclusion Criteria:

1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2

2. Previous autologous stem cell transplantation within 6 months prior to Visit 2

3. Allogeneic stem cell transplantation

4. Radioimmunotherapy