Status:
COMPLETED
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have r...
Detailed Description
As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer...
Eligibility Criteria
Inclusion
- Patient must have confirmed B-CLL.
- Patients must have received at least one prior therapy and must require treatment for active disease
Exclusion
- Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
- History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
- History of human immunodeficiency virus (HIV) positivity.
- Active infection requiring treatment
- Pregnancy or lactation
- Other severe, concurrent diseases or mental disorders
- Central nervous system involvement of chronic lymphocytic leukemia (CLL)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00206726
Start Date
May 1 2005
End Date
April 1 2008
Last Update
August 29 2016
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35223
2
Berkeley, California, United States, 94704
3
Burbank, California, United States, 91595
4
Concord, California, United States, 94520