Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
18 Years
65 Years
Both
Leukemia
Trial Information
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
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
treated with fludarabine with versus without cyclophosphamide.
Secondary
- Compare the incidence of side effects and quality of life of patients treated with
these drugs.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment arms
- Arm I: Patients receive fludarabine IV on days 1-5.
- Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both
arms, treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Michael Hallek, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Medizinische Universitaetsklinik I at the University of Cologne
Authority:
United States: Federal Government
Study ID:
CDR0000455094
NCT ID:
NCT00276848
Start Date:
July 1999
Completion Date:
Related Keywords:
- Leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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