EUCTR2013-003257-20-GB进行中（未招募）1 期
Evaluation of Treosulfan pharmacokinetics (PK) in children undergoing allogeneic haematopoietic stem cell transplantation (HSCT) - Treosulfan PK in children
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
入选标准
- •Patients affected by malignant or non-malignant diseases with an indication to allogeneic HSCT.
- •Patients must meet all of the following criteria for admission in the study:
- •1) age = 28 days and = 18 years old;
- •2) Karnofsky Performance Status = 50 or Lansky Performance Status = 30;
- •3) provide signed, written informed consent from parent or guardian;
- •4) be able to comply with study procedures and follow-up examinations;
- •5) have adequate organ function (as indicated by Table 1, page 27), within 14 days prior enrollment;
- •6) negative pregnancy test in post-pubertal female patients.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients who meet any of the following criteria will be excluded from study admission:
- •1)Patients aged < 28 days and > 18 years old;
- •2)patients with compromised organ function*;
- •3)patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study;
- •4)Known hypersensitivity to Treosulfan or Fludarabine;
- •5)Pregnancy/lactation.
研究者
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