Leukemia, Lymphocytic, Chronic
Conditions
Keywords
CLL, Chronic lymphocytic leukemia, leukemia, Advanced, fludarabine-refractory CLL
Brief summary
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).
Interventions
experimental, forodesine oral dose 200 mg administered daily.
Sponsors
BioCryst Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate after 2 cyclesof forodesine therapy. | 8 weeks |
Countries
United States
Outcome results
None listed