NCT03216070Unknown4 期
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
Hospital Universitario Dr. Jose E. Gonzalez1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Molecular Response at 6 months
研究概览
简要总结
Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.
详细描述
We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a BCR/ABL PCR will be taken to evaluate molecular response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <2 weeks (14 days) of prior FDA approved TKI.
- •ECOG performance of 0-2
- •Adequate end organ function, defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- •Patients must sign an informed consent indicating they are aware of the investigational nature of this study.
排除标准
- •NYHA cardiac class 3-4 heart disease or previous pleural effusion.
- •Pregnancy and lactation
- •Patients with active, uncontrolled psychiatric disorders
研究组 & 干预措施
Arm1 Low Dose Dasatinib
Experimental
We will give 50mg of dasatinib orally daily for 6 months
干预措施: Dasatinib 50 MG (Drug)
结局指标
主要结局
Molecular Response at 6 months
时间窗: 6 months
Molecular Response define as BCR/ABL \<1%
次要结局
- Early Molecular Response at 3 and 6 months(3 and 6 months)
研究者
Dra. Olga Graciela Cantu Rodriguez
MD
Hospital Universitario Dr. Jose E. Gonzalez
研究点 (1)
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