Status:
COMPLETED
Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with t...
Detailed Description
OBJECTIVES: Primary * Compare the effect, in terms of event-free survival, of deferred versus immediate treatment with rituximab, fludarabine, and cyclophosphamide in patients with previously untrea...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Established diagnosis of B-cell chronic lymphocytic leukemia
- First diagnosis within 12 months before inclusion in study
- Previously untreated disease
- Binet stage A disease (Rai stage 0, I, or II)
- PATIENT CHARACTERISTICS:
- Life expectancy \> 6 months
- ECOG performance status 0-2
- Willingness to accept contraception (if randomized to arm I) for the duration of therapy and 12 months thereafter
- Negative serum pregnancy test
- All parameters for risk stratification (lymphocyte doubling time, cytogenetics, unmutated IgVH, and serum thymidine kinase level \> 10) present
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, radiotherapy, or antibody treatment
- No other concurrent chemotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT00275054
Start Date
October 1 2005
End Date
June 1 2015
Last Update
May 23 2019
Active Locations (91)
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1
Universitaetsklinik fuer Innere Medizin I
Vienna, Austria, A-1090
2
Centre Hospitalier Universitaire d'Amiens
Amiens, France, 80054
3
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
4
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107