Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
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:
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.
PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Confirmed diagnosis of B-cell chronic lymphocytic leukemia
Meets 1 of the following criteria:
High-risk disease, as defined by the following:
Low-risk disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Bad Friedrichshall, 74172, Germany
Greifswald, D-17487, Germany
Magdeburg, D-39120, Germany
Murnau am Staffelsee, 82418, Germany
Saarbruecke, N-66113, Germany