Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia
A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
1 other identifier
interventional
20
2 countries
24
Brief Summary
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2004
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 3, 2004
CompletedFirst Posted
Study publicly available on registry
November 4, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 19, 2012
January 1, 2012
3 years
November 3, 2004
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
Secondary Outcomes (3)
Safety and tolerability
Pharmacokinetics (PK) and Pharmacodynamics (PD)
maintenance of response and safety in long-term treatment
Interventions
Eligibility Criteria
You may qualify if:
- Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
- 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
You may not qualify if:
- Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Los Angeles, California, 90024, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Gainesville, Florida, 32611, United States
Unknown Facility
Lecanto, Florida, 34461, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
New Orleans, Louisiana, 70118, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Rolla, Missouri, 65401, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Weil Medical College of Cornell University
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
The Bronx, New York, 10467, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Austin, Texas, 78701, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Abingdon, Virginia, 24211, United States
Unknown Facility
Tbilisi, Georgia, GE-380079, Georgia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2004
First Posted
November 4, 2004
Study Start
March 1, 2004
Primary Completion
March 1, 2007
Study Completion
December 1, 2007
Last Updated
January 19, 2012
Record last verified: 2012-01