Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia

Date de début de l'étude : 9 mars 2000

DISEASE CHARACTERISTICS: Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following: Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Phenotypically characterized as B-CLL Must have one of the following characteristics indicating need for chemotherapy: Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3) Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy At least 10% weight loss within 6 months of study Extreme fatigue Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection Night sweats without evidence of infection No autoimmune anemia or autoimmune thrombocytopenia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 mg/dL unless secondary to tumor Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL Other: No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix No active infection requiring oral or intravenous antibiotics Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: No prior steroid treatment for CLL Radiotherapy: Not specified Surgery: Not specified