Status:
COMPLETED
HuMax-CD20 in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients Failing Fludarabine and Alemtuzumab
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Tumor cell phenotype consistent with B-CLL
- Patients with active B-CLL and with an indication for treatment
- Failing at least one fludarabine-containing treatment regimen
- Failing at least one alemtuzumab-containing treatment regimen
- ECOG Performance Status of 0, 1, or 2
- Life expectancy of at least 4 months
Exclusion
- Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
- Previous autologous stem cell transplantation within 6 months prior to Visit 2
- Allogeneic stem cell transplantation
- Radioimmunotherapy
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00349349
Start Date
June 1 2006
End Date
June 1 2012
Last Update
June 4 2014
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