Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia
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
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:
Binet stage A with B symptoms
Binet stage B or C, meeting 1 of the following criteria:
Previously untreated disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Ansbach, 91522, Germany
Munchber, D-95213, Germany
Postdam, D-14467, Germany
Saarbruecke, N-66113, Germany