NCT02156297Unknown不适用
Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is:
- Definitely diagnosed as AML
- FLT3-ITD mutation has been confirmed
- Accepting the prescription of sorafenib
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definitely diagnosed as AML
- •FLT3-ITD mutation has been confirmed
- •Accepting the prescription of sorafenib
排除标准
- •Can not take drugs orally
- •Can not follow the doctors' advices
- •Other reasons that investigators considered as contra-indications for this study
结局指标
主要结局
Overall Response Rate
时间窗: up to 2 years
Progress-Free Survival
时间窗: up to 2 years
次要结局
- Median time to the onset of sorafenib resistance(up to 2 years)
- Overall Survival(up to 2 years)
- Leukemia-Free Survival(up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
An Open-Label, Non-Comparative, Phase III Study of the Raf-Kinase Inhibitor BAY 43-9006 as a Subsequent to First-Line Therapy in Patients With Advanced Renal Cell CarcinomaCarcinoma, Renal CellNCT00492986Bayer1,150
招募中
3 期
Sorafenib (Soranex)® for prevention of relapse in AML PatientsAcute myeloblastic leukemiaIRCT20140818018842N21Tehran University of Medical Sciences20
已完成
3 期
Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast CancerBreast CancerNCT01234337Bayer537
已完成
2 期
Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCTAcute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)NCT01772953Center for International Blood and Marrow Transplant Research40
已完成
3 期
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular CarcinomaCarcinoma, HepatocellularNCT00105443Bayer602