EUCTR2004-004286-15-DE进行中（未招募）不适用
A Phase II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride (BCX-1777) Infusion in Patients with Advanced T-Cell Leukemia with an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use - N/A
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphoma 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
- •Age - 18 years or older
- •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)
- •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 in such a manner that the risk of pregnancy is minimized
- •Signed informed consent/assent form prior to start of any study specific procedures
- •Are the trial subjects under 18? no
- •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
排除标准
- •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 infection not controlled by oral or IV antibiotics
- •Treatment with any investigational antileukemic 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 a stable dose)
- •Pregnant and/or lactating female
- •Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
研究者
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