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

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