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临床试验/NCT02673008
NCT02673008已完成2 期

Minimal Residual Disease-directed Donor Lymphocyte Infusion for Reduce of Relapse After Allogenetic Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
206
试验地点
1
主要终点
relapse rate

研究概览

简要总结

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD). In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

详细描述

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse remains an important problem. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI), and another transplantation used alone or in combination. However, the efficacy of these interventions is limited. One approach to the relapse problem is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) using immune or molecular techniques.DLI is an effective post-transplantation therapy for prophylaxis of leukemia relapse, but is associated with a substantial risk of GVHD. Whether MRD-directed DLI could improve outcomes remains unclear. In this study, the efficacy of MRD-directed DLI on transplantation outcomes will be evaluated in patients with acute leukemia receiving allo-HSCT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with acute leukemia
  • receiving allo-HSCT

排除标准

  • 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)

结局指标

主要结局

relapse rate

时间窗: 1 year

次要结局

  • overall survival(1 year)
  • disease-free survival(1 year)

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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