Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- relapse rate
研究概览
简要总结
molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.
Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.
the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high risk t (8; 21) AML
- •molecular relapse after allo-SCT
排除标准
- •active graft-versus-host disease
- •uncontrolled severe infection
- •organ function failure
研究组 & 干预措施
interferon
干预措施: Interferon-alpha (Drug)
结局指标
主要结局
relapse rate
时间窗: participants will be followed for an expected average of 365 days
number of participants with morphologic relapse at one year
次要结局
未报告次要终点
研究者
Xiaojun Huang
director of Peking University People's Hospital, institute of hematology
Peking University People's Hospital