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

NCT ID: NCT00289562

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-12-31

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

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

forodesine hydrochloride (BCX-1777)

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denver, Colorado, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

New York, New York, United States

New York, New York, United States

Houston, Texas, United States

Abingdon, Virginia, United States

Countries

United States

Other Identifiers

BCX1777-Bi-04-106

Identifier Type: -

Identifier Source: org_study_id