Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Phase 2
Completed
- Conditions
- Leukemia, Lymphocytic, Chronic
- Registration Number
- NCT00289549
- Lead Sponsor
- BioCryst Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate after 2 cyclesof forodesine therapy. 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center, University of Texas
🇺🇸Houston, Texas, United States