JPRN-jRCTs041190067进行中（未招募）2 期
A Phase II Study of Chemotherapy Combined with Dasatinib for Newly Diagnosed Children with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia - JPLSG-ALL-Ph18
Shimada Hiroyuki0 个研究点目标入组 57 人开始时间: 2019年9月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
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
- >= 1age old 至 <= 19age old（—）
- 性别
- All
入选标准
- •1) Diagnosis of Ph+ALL
- •2) Aged 1-19 years
- •3) ECOG performance status (PS) score of 0-2, or worsening to 3 due to leukemia
- •4) Sufficient hepatic and renal function satisfying the laboratory data listed below
- •a) T-Bil: within 3x of age adjusted upper-limit of normal range
- •b) Creatinine: within 3x of age adjusted upper-limit of normal range
- •5) Registration of JPLSG CHM-14
- •6) Written informed consent obtained from guardians or both of patient and guardians
排除标准
- •1) CNS hemorrhage grade 3 or more of CTCAE v4.03
- •2) Uncontrolled infection
- •3) Pregnancy or high possibility of pregnancy and giving suck woman
- •4) History of congenital or acquired immunodeficiency
- •5) Down syndrome
- •6) QTfc, corrected by Fridericia formula as QTfc = QT/RR*1/3, is 0.45 or more seconds
- •7) Uncontrolled diabetes mellitus
- •8) Liver cirrhosis
- •9) Severe psychiatric disorder
- •10) 3 weeks or more after the start of induction therapy
- •11) History of tyrosine kinase-combined induction therapy
- •12) Any inappropriate status judged by physician.
研究者
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