Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

Not Recruiting

Trial ID: NCT00095381


BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia. Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.

Official Title

A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use

Stanford Investigator(s)


Inclusion Criteria:

   - Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)

   - Failure to have responded to one or more standard regimens for their disease.

   - Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria

   - All ages are eligible

   - Life expectancy of at least 3 months

   - Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase
   [ALT] not >3 times upper limits or normal [ULN])

   - Adequate kidney function (calculated creatinine clearance >50 mL/min)

   - Negative urine pregnancy test within 2 to 7 days prior to the start of study
   treamtment 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

   - Signed informed consent/assent form (ICF) prior to start of any study specific

Exclusion Criteria:

   - Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)

   - Patients with known Hepatitis B and/or Hepatitis C active infection

   - Patients with active CMV infection

   - Tumor-related central nervous system (CNS) leukemia requiring active treatment

   - Active serious infection not controlled by oral or IV antibiotics

   - Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7
   days prior to study entry, unless full recovery from side effects has occurred.

   - Rapidly progressive disease with compromised organ function judged to be
   life-threatening by the investigator

   - Concurrent treatment with other anticancer agents (corticosteroid use will not be
   excluded, but patient must remain on the stable dose)

   - Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)

   - Pregnant and/or lactating women


drug: forodesine hydrochloride (BCX-1777)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nadeem Mukhtar

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