Clinical trial NCT00419081 (phase 2, status: terminated)
Conditions: leukemia, lymphoma
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: forodesine hydrochloride sterile solution, 5 mg/ml, forodesine hydrochloride capsules (100 mg)
SMILES: OC[C@H]1N[C@H]([C@H](O)[C@@H]1O)C1=CNC2=C1N=CNC2=O, OC[C@H]1N[C@H]([C@H](O)[C@@H]1O)C1=CNC2=C1N=CNC2=O
Reason stopped: 
    issues with manufacturing
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic
             leukemia/lymphoma (World Health Organization [WHO] classification).

          -  Failure to have responded to or relapsed after two or more treatment regimens for
             their disease, one of which could be HSCT.

          -  Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see
             Appendix A).

          -  Eighteen years of age and older.

          -  Life expectancy of at least three months.

          -  Adequate liver function (aspartate aminotransferase [AST] and/or alanine
             aminotransferase [ALT] ≤3 times upper limit of normal), unless related to the
             underlying leukemia.

          -  Negative serum or urine pregnancy test within two to seven 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) prior to start of any study-specific procedures.

          -  Willing and able to provide authorization for the use and disclosure of personal
             health information in accordance with Health Insurance Portability and Accountability
             Act (HIPAA) policy (U.S. patients only).

        Exclusion Criteria:

          -  Patients with known human immunodeficiency virus (HIV) infection or human T
             lymphotrophic virus 1 (HTLV-1).

          -  Patients with active hepatitis B or C infection.

          -  Patients with clinical evidence of active central nervous system (CNS) leukemia.

          -  Active serious infection not controlled by oral or intravenous antibiotics.

          -  Patients with a calculated creatinine clearance of <50 mL/min.

          -  Prior treatment with any investigational antileukemic or chemotherapy agent within
             seven days prior to study entry or 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.

          -  Concurrent treatment with other antileukemia agents (CNS prophylaxis [e.g.,
             intrathecal methotrexate, cytarabine, or hydrocortisone] and corticosteroid use will
             not be excluded, but must first be approved by the Medical Monitor) (see Sections
             9.2.1 and 9.2.2).

          -  Pregnant and/or lactating female.

          -  Patients who cannot swallow or who have chronic gastrointestinal disease or conditions
             that may hamper compliance and/or absorption of the product.

          -  Hypersensitive or intolerant to any component of the study drug formulations.

          -  Patients who have received prior forodesine treatment.