JPRN-jRCTs051180191已完成2 期
A Multi-Center Phase II Study in Children with Newly Diag nosed AcutePromyelocytic Leukemia (APL) - AML-P13
TAKAHASHI Hiroyuki0 个研究点目标入组 32 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
Three-year EFS rate in the JPLSG AML-P13 study was 96.3%. Molecular remission rate and 3-year OS rate was 100.0% and 100.0%, respectively, indicating favorable outcome in patients registered with this study. ATO-related grade 3 and higher non-hematological AEs were observed only in 3. Hence, ATO could be administered safely in children with APL. In conclusion, AML-P13 study conferred favorable outcome in children with APL and provided substantial findings especially in safety and efficacy of ATO.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 18age old（—）
- 性别
- All
入选标准
- •Patient with a diagnosis of APL genetically or cytogenetically diagnosed by either one of three methods; karyotyping, FISH, or RT-PCR.
- •ECOG performance status score of 0-2, or of 3 when caused by leukemia.
- •No previous treatment.
- •Written informed consent obtained either from patient or guardians.
排除标准
- •17q12/RARA not detected genetically and cytogenetically
- •APL with t(11;17)(q23;q12)/PLZF-RARA
- •CNS hemorrhage which is likely to interfere protocol therapy
- •Secondary APL due to previous chemotherapy or radiation therapy
- •Unmanageable infectious disease including tuberculosis
- •Any inappropriate status judged by physician
研究者
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