jRCTs051180191已完成不适用
A Multi-Center Phase II Study in Children with Newly Diag nosed Acute Promyelocytic Leukemia (APL) (AML-P13)
未提供0 个研究点目标入组 30 人开始时间: 2015年1月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 0age No limit 至 18age old not（—）
- 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
结局指标
主要结局
-
Three-year event-free survival rate
次要结局
未报告次要终点
研究者
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