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

Inclusion Criteria

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