Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
NCT ID: NCT00095381
Last Updated: 2012-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2004-03-31
2007-12-31
Brief Summary
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Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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forodesine hydrochloride (BCX-1777)
Eligibility Criteria
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Inclusion Criteria
* Failure to have responded to one or more standard regimens for their disease.
* Performance status of \<=2 by Eastern Cooperative Oncology Group (ECOG) criteria
* All ages are eligible
* Life expectancy of at least 3 months
* Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits or normal \[ULN\])
* Adequate kidney function (calculated creatinine clearance \>50 mL/min)
* Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
* Signed informed consent/assent form (ICF) prior to start of any study specific procedures
Exclusion Criteria
* Patients with known Hepatitis B and/or Hepatitis C active infection
* Patients with active CMV infection
* Tumor-related central nervous system (CNS) leukemia requiring active treatment
* Active serious infection not controlled by oral or IV antibiotics
* Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
* Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
* Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
* Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
* Pregnant and/or lactating women
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Los Angeles, California, United States
Palo Alto, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Lecanto, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Rolla, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Weil Medical College of Cornell University
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Spartanburg, South Carolina, United States
Austin, Texas, United States
Houston, Texas, United States
Abingdon, Virginia, United States
Tbilisi, Georgia, Georgia
Countries
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Other Identifiers
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BCX1777-T-04-201
Identifier Type: -
Identifier Source: org_study_id
NCT00086788
Identifier Type: -
Identifier Source: nct_alias
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