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
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : forodesine hydrochloride (BCX-1777)
Phase: Phase 2
Ages Eligible For Study:
- 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 procedures