Phase II 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