Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria

• •1. Specific Diagnosis of B-Cell CLL
• •1.1 An absolute lymphocytosis of \> 5,000/µl
• •1.1.1 Morphologically, the lymphocytes must appear mature with \< 55% prolymphocytes.
• •1.1.2 Bone marrow examination must include at least a unilateral aspirate and biopsy. The aspirate smear must show \> 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL. The overall cellularity must be normocellular or hypercellular.
• •1.1.3 Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23, CD24) with the CD5 antigen, in the absence of other pan-T-cell markers. Additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density. Patients with bright surface immunoglobulin levels must have CD23 co-expression.
• •1.2 Staging
• •1.2.1 Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV) per the protocol.
• •1.2.2 Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
• •* Massive or progressive splenomegaly and/or lymphadenopathy
• •* Presence of weight loss \> 10% over the preceding 6 month period;
• •* Grade 2 or 3 fatigue
• •* Fevers \> 100.5°C or night sweats for greater than 2 weeks without evidence of infection
• •* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months.
• •2. Prior Treatment: No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL.
• •3. No medical condition requiring chronic use of oral corticosteroids.
• •4. Age ≥18 years.
• •5. Performance Status 0 - 2.
• •6. No HIV disease. Due to alterations in host immunity, patients with HIV may not be enrolled.
• •7. Non-pregnant and non-nursing. Due to the unknown teratogenic potential of Campath-1H, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.
• •8. Initial Required Laboratory Values:
• •Creatinine \<1.5 x upper limit of institutional normal value Coomb's Testing NEGATIVE