Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. It is not yet known whether fludarabine is more effective than
chlorambucil in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as
first-line therapy compared to chlorambucil in treating older patients with previously
untreated 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.
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