JPRN-UMIN000029275已完成1 期
A pilot phase I study of azacitidine for the first relapsed patients with infant acute lymphoblastic leukemia and MLL gene rearrangement - AZA-MLL-P16
ational Center for Child Health and Development0 个研究点目标入组 1 人开始时间: 2017年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
Primary endpoint of this trial was incidence of dose limiting toxicity (DLT) of the investigational drug azacytidine. No DLT was observed in DL1 for the registered patient. However, at least three patients are required to evaluate the incidence of DLT in DL1; therefore, DLT of azacitidine could not be evaluated in this study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 6years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients should be excluded if either of the below criteria is met: (1) Patients with uncontrollable infections. (2) Patients with congenital heart disease which require any interventions. (3) Patients with somatic chromosomal abnormalities. (4) Patients with active hemorrhage at study entry. (5) Patients with CNS symptoms at study entry. (6) Patients with other malignant diseases. (7) Patients with isolated extramedullary relapse. (8) Patients with CNS relapse. (9) Patients not eligible for the study entry decided by the primary/co-investigators of the study.
研究者
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