Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days
 each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour
 prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy
 (28 days).
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