Status:
COMPLETED
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Lead Sponsor:
German CLL Study Group
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 * Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)
- Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms
- Binet stage A is acceptable, if there are B-symptoms
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 6 months
- No severe organ dysfunction
- No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia
- PRIOR CONCURRENT THERAPY:
- No prior or concurrent chemotherapy
Exclusion
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00276848
Start Date
July 1 1999
End Date
July 1 2007
Last Update
May 23 2019
Active Locations (135)
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1
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
2
Hanuschkrankenhaus
Vienna, Austria, A-1140
3
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
Ansbach, Germany, D-91522
4
Internistische Praxis - Arnstadt
Arnstadt, Germany, D-99310