Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria: Relapsed or refractory chronic lymphocytic leukemia. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL. Expected remaining life span > or = three months. ECOG performance status 0 - 2. 18 years or of legal age. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal. Negative serum pregnancy test, if fertile female. Willingness and ability to sign an informed consent document. Exclusion Criteria: Evidence of CNS involvement. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. Previous therapy with Campath. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System. Concurrent immunotherapy. Concurrent use of steroids. Use of an investigational medication or device within 1 month of initiating study therapy. Patients who have had allogeneic bone marrow transplantation. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal. AST or ALT > 2.5 times the upper limit of normal. Any condition or any medication which may interfere with the conduct of the study.