Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
- 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.
- Compare the incidence of toxicity, especially infections, in patients treated with
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne
United States: Federal Government