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临床试验/NCT02888522
NCT02888522Unknown不适用

Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Percentage of recipient chimerism

研究概览

简要总结

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.

The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.

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

入选标准

  • Acute myeloid leukemia
  • Allogeneic stem cell transplantation (related or unrelated)

排除标准

  • Age under 18 years
  • Cord blood transplantation

结局指标

主要结局

Percentage of recipient chimerism

时间窗: 3 months

whole blood chimerism

次要结局

  • Percentage of relapse at 1 year(Relapse rate at 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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