Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria: Ages 18 years and older Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy Primary resistance to fludarabine-based therapy (no complete response [CR] or partial response [PR]) or progressive disease within 6 months of response to prior fludarabine containing regimen. ECOG performance status of 0, 1, 2 or 3 Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug. Exclusion Criteria: Pregnant or nursing Unable or unwilling to sign consent Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy Active serious infections that are not controlled by antibiotics ECOG performance status 4 Inadequate renal function: creatinine 2.0 or more unless related to the disease Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease Known positive test for HIV Patients with known hepatitis B and/or hepatitis C active infection