A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab, and Rituximab

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:

- Minimum threshold peripheral lymphocyte count of 5 x 10^9/L (CLL variant) OR
palpable adenopathy > 1 cm or palpable splenomegaly (SLL variant)

- Immunophenotypic demonstrations of a population of B-lymphocytes (as defined by
CD19+) that are monoclonal (by light-chain exclusion) AND have ≥ 3 of the
following characteristics:

- CD5+

- CD23+

- Dim surface light chain expression

- Dim surface CD20 expression

- FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative for
cyclin D1 expression (to exclude mantle cell lymphoma)

- Has progressive, symptomatic CLL, defined by at least one of the following:

- Weight loss > 10% within the past 6 months attributable to progressive CLL
(grade 2 or higher)

- Extreme fatigue attributable to progressive CLL (grade 3 or higher)

- Fevers > 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)

- Night sweats without evidence of infection (drenching)

- Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or
platelet count < 100 x 10^9/L

- Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any
dimension

- Largest lymph nodes involved in the neck, axilla, and groin need to be
measured and followed for response

- No massive splenomegaly > 6 cm below left costal margin, at rest, on clinical
examination

- No lymphadenopathy > 5 cm in any diameter

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Creatinine ≤ 2 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN

- AST ≤ 3.0 times ULN (unless due to CLL involvement of the liver)

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 12 months after
completion of study therapy

- None of the following comorbid conditions:

- New York Heart Association class III or IV heart disease

- Recent myocardial infarction (within the past month)

- Uncontrolled infection

- HIV/AIDS

- Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)

- Positive hepatitis C serology

- No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood
cell aplasia

- No other active primary malignancy requiring treatment or that limits survival to ≤ 2
years, except for in situ carcinoma of the cervix or breast or non-metastatic basal
cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

- No prior treatment for CLL

- More than 4 weeks since prior major surgery

- No concurrent continuous systemic corticosteroids

- Prior corticosteroids are allowed but not at time of pre-registration to the
study