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临床试验/NCT02474290
NCT02474290已完成2 期

Sorafenib for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3-ITD Positive Acute Myeloid Leukemia

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2015年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
202
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 evaluate the efficacy of sorafenib for prophylaxis of leukemia relapse in allogeneic stem cell transplant (Allo-HSCT) recipients with FLT3-ITD positive acute myeloid leukemia (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. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the outcomes of some FLT3-ITD-positive AML, a significant number will suffer disease recurrence after allo-HSCT. Sorafenib, an inhibitor of multiple kinases including FLT3, has shown promising activity in FLT3-ITD-positive AML. Recent studies have shown that sorafenib monotherapy or in combination with chemotherapy are effective in attaining CR, but they do not have significant improvement in relapse. Currently, prophylactic use of sorafenib after allo-HSCT has been rarely reported, and whether it can improve outcomes of FLT3-ITD-positive AML remains unclear.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

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 (investigators' decision)

研究组 & 干预措施

Sorafenib group

Experimental

Sorafenib will be used from day 30 to 180 post-transplantation.

干预措施: Sorafenib (Drug)

结局指标

主要结局

Incidence of leukemia relapse

时间窗: 1 year

次要结局

  • Overall survival(3 year)
  • leukemia-free survival(3 year)
  • Incidence of side effect of sorafenib(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifa Liu

Professor

Nanfang Hospital, Southern Medical University

研究点 (1)

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