Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia
Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia
This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.
DISEASE CHARACTERISTICS:
Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
Meets 1 of the following criteria:
Binet stage C disease
Binet stage B disease AND ≥ 1 of the following signs or symptoms*:
No Binet stage A disease
No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Westmead - Wentworthville, New South Wales 2145, Australia
Mont-Godinne Yvoir, 5530, Belgium
Pilsen-Lochotin, 30460, Czechia
Ansbach, 91522, Germany
Greifswald, D-17475, Germany
Koblez, D-56068, Germany
Magdeburg, D-39120, Germany
Sanderbusch, 26452, Germany