CTRI/2011/08/001975已完成2 期
A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase CML or with Ph+ Leukemias Resistant or Intolerant to Imatinib
BristolMyers Squibb India Pvt Ltd0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
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
入选标准
- •Inclusion criterias:
- •1)Age 2 to 18 years.
- •2)Lansky or Karnofsky scale >50.
- •3)Life expectancy more than 12 weeks.
- •4)Any toxicity from recent therapies recovered to baseline or grade 1.
- •5)Adequate hepatic and renal function.
排除标准
- •Prior therapy with dasatinib
- •Eligible for potentially curative therapy including hematopoietic stem-cell transplantation
- •Symptomatic central nervous system disease
- •Isolated extramedullary disease
- •Medical condition significantly impairing ability of patient to receive dasatinib
- •T315I mutation in BCR-AB
研究者
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