Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia

B-cell Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289562
• Other study ID #: BCX1777-Bi-04-106
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 8, 2006
• Last updated: January 19, 2012
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2012
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• forodesine hydrochloride (BCX-1777)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States,