JPRN-jRCTs041180144已完成2 期
A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia - JPLSG-ALL-Ph13
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sato Atsushi
- 入组人数
- 43
研究概览
简要总结
The ALL-Ph13 was the first trial for Japanese children with Philadelphia chromosome-positive ALL in which TKIs were continuously administered with chemotherapy. Despite the limited use of SCT, this study showed more than 60% of the 3-year EFS. After the amendment of the protocol, the toxicities of the ALL-Ph13 were acceptable. The ALL-Ph13 showed comparable outcomes to other clinical trials using TKIs with chemotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 1age old 至 <= 19age old（—）
- 性别
- All
入选标准
- •1) diagnosis of Ph+ALL
- •2) age between 1 and 19 years old
- •3) ECOG performance status (PS) score of 0-3
- •4) no history of previous chemotherapy or radiation therapy
- •5) written informed consent obtained from patient or guardians.
排除标准
- •1) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
- •2) pregnancy or high possibility of pregnancy and giving suck wiman.
- •3) history of congenital or acquired immunodeficiency.
- •4) any inappropriate status judged by
研究者
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