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Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)

NCT00289549•BioCryst Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

MD Anderson Cancer Center, University of Texas

Houston, Texas, United States

Key Dates

Start Date

June 1, 2005

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

February 8, 2012

Enrollment

ACTUAL participants

Conditions

Leukemia, Lymphocytic, Chronic

Interventions

forodesine hydrochloride (BCX-1777)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

Exclusion Criteria

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