A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

DISEASE CHARACTERISTICS:

Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following criteria:

Peripheral blood absolute lymphocyte count > 5,000/mm³
Small- to moderate-size lymphocytes with < 55% prolymphocytes, atypical lymphocytes, or lymphoblasts

Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:

Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)
B-cell expresses either lambda or kappa light chains
Surface immunoglobulin with low-cell surface density expression NOTE: *Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL

Requires therapy, as indicated by ≥ 1 of the following criteria:

Unintentional weight loss > 10% within the past 6 months
Extreme fatigue (i.e., ECOG performance status 2)
Fevers > 100.5°F for 2 weeks without evidence of infection
Night sweats without evidence of infection
Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet count < 100,000/mm³)
Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly
Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage
Progressive lymphocytosis with an increase of > 50% over 2 months or an anticipated doubling time < 6 months
Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC ≥ 1,000/mm³*
Platelet count ≥ 50,000/mm³*
Hemoglobin ≥ 10 g/dL*
Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 40 mL/min
Bilirubin < 2 mg/dL
AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
No active autoimmune anemia or thrombocytopenia
No active infection requiring oral or intravenous antibiotics
No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.

PRIOR CONCURRENT THERAPY:

Prior corticosteroid therapy allowed
No prior cytotoxic therapy (other than corticosteroids)