Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Sometimes, the cancer may not need treatment until it progresses. In this case, observation
may be sufficient. It is not yet known whether fludarabine is more effective than observation
in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works
compared to observation only in treating patients with stage 0, stage I, or stage II B-cell
chronic lymphocytic leukemia.
OBJECTIVES:
- Identify prognostic factors that predict a short survival in patients with stage 0-II
B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.
OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs
low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk
group are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine.
- Arm II: Patients undergo observation only.
PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.
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