IRCT20140818018842N21招募中3 期
A Pilot Study of Sorafenib (Soranex)® (FLT3 Inhibitor) Administeration as Maintenance Therapy Following Allogeneic Transplant for AML Patients with FLT3/ITD mutation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
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
- 18 years 至 55 years（—）
- 性别
- All
入选标准
- •Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT
- •Peripheral blood chimerism studies showing >/= 90% of all cells are of donor origin
- •ECOG performance status 0-2
- •Able to swallow whole pills
- •Adequate hematologic and hepatic function
排除标准
- •Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 after HSCT
- •Active acute graft vs host disease requiring an equivalent dose of > 0.5 mg/kg/day of prednisone
- •Ongoing uncontrolled infection
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Known HIV infection or chronic hepatitis B or C
- •Any other hemorrhage/bleeding or dermal complication related to intervention CTCAE v. 4.0 > = Grade 3 within 4 weeks of starting study drug
- •Receiving any other investigational agents
研究者
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