Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- relapse rate
研究概览
简要总结
This study aimed to evaluate the efficacy of interferon α among patients undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after transplantation.
Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute leukemia and many other hematological malignancies. However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.The persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen patients with a high risk of relapse to provide timely intervention and prevent post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients with MRD-positive after transplantation.
The study hypothesis:
Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can reduce relapse rate.
详细描述
Standard risk acute leukemia patients (except t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities.) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation who were minimal residual disease positive after hematopoietic stem cell transplantation received interferon α-2b. The end points were safety and immunologic response. Following time is 12 months.
Primary Outcome Measures:
*The feasibility and efficacy of administering of subcutaneous interferon α-2b in this patient population. [ Time Frame: 1 years ]
Secondary Outcome Measures:
*The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients after unmanipulated blood and marrow transplantation [ Time Frame: 1 years ] Estimated Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016
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
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual disease positive after hematopoietic stem cell transplantation
排除标准
- •Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment
研究组 & 干预措施
interferon Alfa-2b group
Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b
干预措施: Interferon Alfa-2b (Drug)
结局指标
主要结局
relapse rate
时间窗: participants will be followed for an expected average of 1 year
number of participants with morphologic relapse at one year
次要结局
- The immunologic impact of subcutaneous interferon α-2b(participants will be followed for an expected average of 1 year)
研究者
Xiaojun Huang
Peking University Institute of Hematology
Peking University People's Hospital