Status:
COMPLETED
Fludarabine or Observation 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
18-75 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the can...
Detailed Description
OBJECTIVES: * Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only. OUTLINE: This is...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of B-cell chronic lymphocytic leukemia
- Rai stage 0-II (Binet stage A) disease
- Meets 1 of the following criteria:
- High-risk disease, as defined by the following:
- Serum thymidine kinase level \> 7.0 U/L
- Elevated β2-microglobulin level
- Presence of non-nodular bone marrow infiltration
- Short lymphocyte doubling time
- Low-risk disease
- Meets none of the criteria (as listed above) for high-risk disease
- PATIENT CHARACTERISTICS:
- Performance status
- Not specified
- Life expectancy
- More than 6 months
- Hematopoietic
- No autoimmune hemolytic anemia
- No thrombocytopenia
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No severe organ dysfunction
- No other prior or concurrent malignancy
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
Exclusion
Key Trial Info
Start Date :
April 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT00262782
Start Date
April 1 1997
End Date
June 1 2010
Last Update
February 20 2020
Active Locations (117)
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1
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
Vienna, Austria, 1090
2
Hanuschkrankenhaus
Vienna, Austria, A-1140
3
Klinikum St. Marien
Amberg, Germany, D-92224
4
Internistische Praxis - Arnstadt
Arnstadt, Germany, 99310