Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia
Completed · Phase 1/Phase 2
Conditions studied: B-cell Acute Lymphoblastic Leukemia
In brief
A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use of Forodesine Hydrochloride
Key facts
- Study ID
- NCT00289562
- Run by
- BioCryst Pharmaceuticals
- People needed
- 20
- Starts
- 2004-09-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2012-01-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented B-cell acute lymphoblastic leukemia (B-ALL), which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
- Must have failed at least 1 treatment regimen for B-ALL, which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
- Performance status of ≤2 by Eastern Cooperative Oncology Group (ECOG) criteria
- Any age is allowed
- Life expectancy of at least 3 months
- Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits of normal [ULN])
- Adequate kidney function (calculated creatinine clearance >40 mL/min)
- Negative serum or urine pregnancy test within 2 to 7 days prior to the start of study treatment 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 in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Signed informed consent form (ICF), minor assent form (if applicable), prior to start of any study-specific procedures
You may not qualify if…
- Active serious infection not controlled by oral or intravenous antibiotics
- Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given
- Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator
- Patients with clinical evidence of active central nervous system (CNS) disease
- Concurrent treatment with other anticancer agents
- Pregnant and/or lactating female
- Patients with known human immunodeficiency virus (HIV) infection HIV testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
- Patients with known active hepatitis B and/or hepatitis C infection Hepatitis testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
- Hypersensitive or intolerant to any component of the study drug formulation
Where it is running
- Study site — Denver, Colorado, United States
- Study site — Chicago, Illinois, United States
- Study site — Kansas City, Kansas, United States
- Study site — New York, New York, United States
- Study site — New York, New York, United States
- Study site — Houston, Texas, United States
- Study site — Abingdon, Virginia, United States
Full record on ClinicalTrials.gov
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