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

You may be eligible if

• 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)