Clinical trial NCT00289562: Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
Keywords: B-cell
leukemia
B-lymphoblastic leukemia
lymphoma
B-All
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Houston
country: United States
state: Texas
city: Abingdon
country: United States
state: Virginia
Study officials:
References: