Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Patients With FLT3-ITD Positive Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Incidence of leukemia relapse
研究概览
简要总结
The purpose of this study is to reveal the influence of co-existing mutations on the efficacy of sorafenib maintenance after allogeneic hematopoietic stem cell transplantation for patients with FLT3-ITD AML.
详细描述
Internal tandem duplication of FMS-like tyrosine kinase 3 (FLT3-ITD) mutations have been reported in 20%-30% of patients with acute myeloid leukemia (AML). FLT3-ITD-positive AML patients have an inferior survival, primarily due to lower complete remission (CR) rate and higher relapse rate. Our previous studies demonstrated that post-transplantation sorafenib maintenance could improve the outcomes of FLT3-ITD-positive AML patients. However, whether other co-existing mutations influence the efficacy of post-allo-HSCT sorafenib maintenance remains unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FLT3-ITD Positive AML
- •Allo-HSCT Recipients
排除标准
- •cardiac dysfunction (particularly congestive heart failure)
- •hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
- •renal dysfunction (creatinine clearance rate < 30 mL/min)
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (according to the investigators' decision)
研究组 & 干预措施
Sorafenib group
Patients assigned to this group received sorafenib post-transplantation.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Incidence of leukemia relapse
时间窗: 2 year
次要结局
- Overall survival(2 year)
- Leukemia-free survival(2 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University