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

Inclusion Criteria

• •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)