Status:
COMPLETED
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
BioCryst Pharmaceuticals
Conditions:
Leukemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 hour...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00289549
Start Date
June 1 2005
End Date
January 1 2009
Last Update
February 8 2012
Active Locations (1)
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1
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States, 77030