EUCTR2007-001339-69-IT进行中(未招募)不适用
Protocol for standardized diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia (CML). A multicenter, non-randomized, open, prospective clinical trial - CML-paed-II-Study
THE TECHNICAL UNIVERSITY OF DRESDE0 个研究点目标入组 150 人开始时间: 2008年2月6日最近更新:
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
- 入组人数
- 150
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
- •- Newly diagnosed Ph+ or BCR-ABL-positive CML - Male and female patients aged 0 to 18 years - Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- CML without BCR-ABL rearrangement detectable by PCR - Pretreatment with Interferon-alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients. - Any other severe underlying disease beside CML. - Age > 18 years - Pregnant or lactating women - Subjects unlikely to comply with the requirements of the protocol
研究者
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