Status:
COMPLETED
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividin...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL)
- Advanced or progressive disease with ≥ 2 active clinical signs
- PATIENT CHARACTERISTICS:
- Fertile patients must use adequate contraception
- No positive Coomb's test with signs of hemolysis
- No active infection
- No uncontrolled severe disease
- No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- No other malignancies within the past 2 years except for adequately treated malignancies
- No significant traumatic injury within the past 4 weeks
- No coexisting medical or psychological condition that would limit study compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for CLL
- No major surgery within the past 4 weeks
- No prior chemotherapy
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00462332
Start Date
May 1 2007
End Date
June 1 2011
Last Update
September 6 2013
Active Locations (23)
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1
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
2
Universita Degli Studi di Bari
Bari, Italy, 70124
3
Universita Cattolica del Sacro Cuore - Campobasso
Campobasso, Italy, 86100
4
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy, 95124