A phase II, Multi-Centre, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with Advanced T-Cell Leukemia with an Option of Long-Term Forodesine Hydrochloride Use - ND

BIOCRYST PHARMACEUTICALS INC.0 个研究点目标入组 65 人开始时间: 2007年5月15日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphoma ot 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. Age - 18 years or older. Life expectancy of at least 3 months. Adequate liver function (aspartate transaminase [AST] ond/or alanine transaminase [ALT] not > 3 times upper limits of normal. Adequate kidney function (calculated creatinine clearance >50 mL/min). Negative 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. Signed informed consent/assent form prior to start of any study specific procedures.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with known Human Immunodeficiency Virus (HIV)infection or human T-cell leukemia virus Type 1 (HTLV-1). Patients with known Hepatitis B and/or Hepatitis C active infection. Tumor-related central nervous system (CNS) leukemia requiring active treatment. Active serious infections not controlled by oral or IV antibiotics. Treatment with any investigational antileukemic agent or chemotherapy 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 stable dose). Pregnant and/or lactating females. Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary syndrome)

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