EUCTR2008-000424-86-NL进行中（未招募）不适用
Development and introduction of a pediatric liquid formulation of 6-mercaptopurine for treatment of leukemia - 6MP formulation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
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
- •-Histologically or cytologically confirmed diagnosis of ALL
- •-Inclusion in DCOG ALL-10 or Interfant-06 protocol
- •-Recovered from acute side-effects of previous treatment blocks
- •-Lansky play score > 60; or Karnofsky performance status > 60
- •-Normal liver function defined as less than or equal to NCI-CTG grade 1 (max 2.5 x ULN for transaminases and bilirubin)
- •-Able to comply with scheduled follow-up and with management of toxicity
- •-Age 1 month-18 years
- •-Available venous access port
- •-Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patient refusal or parent refusal
- •-Patients with pre-existing liver disease
- •-Other serious illnesses or medical conditions
研究者
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