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临床试验/NCT02568241
NCT02568241Unknown1 期

Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
1 期
入组人数
42
试验地点
1
主要终点
Leukemia free survival

研究概览

简要总结

This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b after prophylactic DLI following hematopoietic stem cell transplantation in patients with high-risk AL can further reduce relapse rate and improve leukemia-free survival.

详细描述

High risk acute leukemia patients (except t(9;22)(q34; q11) cytogenetic abnormalities.) received interferon α-2b after prophylactic DLI at day 30-60 after unmanipulated blood and marrow transplantation. The end points were safety, leukemia-free survival, and immunologic response. Following time is 12 months.

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
2 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had high-risk acute leukemia after hematopoietic stem cell transplantation

排除标准

  • Patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse

结局指标

主要结局

Leukemia free survival

时间窗: Participants will be followed for an expected average of 3 years

Number of participants survived without leukemia at three years

次要结局

未报告次要终点

研究者

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

Xiaojun Huang

Principal Investigator

Peking University People's Hospital

研究点 (1)

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