Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
OBJECTIVES:
Primary
- Compare the overall and progression-free survival of older patients with previously
untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
- Compare the duration of remission in patients treated with these regimens.
Secondary
- Compare the incidence of toxicity, especially infections, in patients treated with
these regimens.
- Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for
up to 6 courses.
- Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days
for up to 12 months.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Michael Hallek, MD
Study Chair
Medizinische Universitaetsklinik I at the University of Cologne
United States: Federal Government
CDR0000455042
NCT00262795
September 2003
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