Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, 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 giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Ansbach, D-91522, Germany
Berlin, D-13122, Germany
Greifswald, D-17487, Germany
Magdeburg, D-39120, Germany
Postdam, D-14467, Germany
Saarbruecke, D-66113, Germany
Tübingen, D-72070, Germany