A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria: * Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. * No previous therapy for CLL. * Expected remaining life span greater than or equal to six months. * 18 years or older. * Willingness and ability to sign an informed consent. Exclusion Criteria: * Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. * History of other malignancy which could affect the diagnosis or assessment of OSI-461. * Previous therapy for CLL. * Use of an investigational medication or device within one month of initiating study therapy. * Concurrent immunotherapy. * Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). * Any condition or any medication which may interfere with the conduct of the study. * Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. * Evidence of CNS involvement. * Pregnant or nursing women.