Status:
COMPLETED
Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
Lead Sponsor:
German CLL Study Group
Conditions:
Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them...
Detailed Description
OBJECTIVES: * Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia. * Determine the res...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)
- Fludarabine-refractory disease
- Requires treatment
- PATIENT CHARACTERISTICS:
- Life expectancy more than 6 months
- ECOG 0-2
- No severe organ dysfunction
- No other concomitant or previous neoplasms
- No autoimmune hemolytic anemia or thrombocytopenia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Up to 5 prior chemotherapy regimens allowed
Exclusion
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00274976
Start Date
September 1 2002
End Date
August 1 2009
Last Update
November 6 2013
Active Locations (35)
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1
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria, A-1090
2
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany, 91522
3
Specialist Practice for Oncology
Aschaffenburg, Germany, 63739
4
Humaine - Clinic
Bad Saarow, Germany, 15526