Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia

Inclusion Criteria

• •Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive clone.
• •Rai Stage I through IV disease with evidence of progression as evidenced by the presence of one or more of the following:1. Disease-related B symptoms (fever of greater than 38 celsius (100.5 F) for greater than or equal to 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss \>10% within previous 6 months. 2. Evidence of progression marrow failure as manifested by: a. decrease in hemoglobin to \<11g/dL or b. decrease in platelet count to \<100x10 to the ninth/L within the previous 6 months or c. decrease in absolute neutrophil count (ANC) to \<1.0x10 to the ninth/L within the previous 6 months. 3. Progressive splenomegaly to \>2 cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinic visits greater than or equal to 2 weeks apart. 4. Progressive lymphadenopathy with at least 5 sites of involvement with either two nodes at least 2cm in longest diameter or one node greater than or equal to 5cm in longest diameter with progressive increase over 2 consecutive visits greater than or equal to weeks apart. 5. Progressive lymphocytes with an increase of \>50% over a 2-month period, or an anticipated doubling time of less than 6 months.
• •Received no previous chemotherapy for B-CLL.
• •Life expectancy of at least 12 weeks.
• •WHO performance status of 0, 1, or 2.
• •Serum creatinine less or equal to 2.0 times the institutional upper limit of normal (ULN) value.
• •Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal to 2 times the institutional ULN value, unless directly attributable to the disease.
• •Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization. Male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months after study therapy.
• •Signed, written informed consent.
• •18 years of age or older.