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.