A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) 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)