JPRN-jRCTs041210044招募中2 期
Multicenter, open-label, uncontrolled study of azacitidine therapy for juvenile myelomonocytic leukemia - JPLSG-JMML-20
Muramatsu Hideki0 个研究点目标入组 30 人开始时间: 2021年7月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 < 10age old（—）
- 性别
- All
入选标准
- •(1) Cases with a clinical diagnosis of JMML based on the JMML diagnostic criteria.
- •(2) Have submitted or are able to submit samples for central testing.
- •(3) Consent for CHM-14 was obtained prior to obtaining consent to participate in this study.
- •(4) Age at diagnosis is less than 10 years old.
- •(5) The patient has sufficient organ function to meet the following three criteria at the same time. Laboratory values within 7 days before the date of enrollment.
- •a) D-Bil level: less than 1.5 mg/dL
- •b) Creatinine: less than 3 times the upper limit of the age-specific test reference value
- •c) Left ventricular ejection fraction (EF) >=50% by echocardiography
- •(6) Adequate explanations and written consent have been obtained from the proxy.
排除标准
- •(1) Noonan syndrome (a case of PTPN11 germ cell mutation)
- •(2) Associated with difficult-to-control infections (including active tuberculosis and HIV antibody-positive cases).
- •(3) Relapse cases with a history of hematopoietic cell transplantation.
- •(4) Any other case deemed inappropriate by the doctor in charge.
研究者
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