NCT03631563Unknown2 期
Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- incidence of GVHD
研究概览
简要总结
Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent
- •Aged <65 years
- •Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females.
- •Any co-morbidity precluding the administration of ATG or ATG-F.
研究组 & 干预措施
Arm 1
Experimental
ATG-F treated
干预措施: Immunosuppressive Agent (Drug)
Arm 2
Active Comparator
ATG treated
干预措施: Immunosuppressive Agent (Drug)
结局指标
主要结局
incidence of GVHD
时间窗: 1 year
次要结局
- leukemia-free survival(1 year)
- treatment-related mortality(1 year)
研究者
Ting YANG
Prof.M.D.Ph.D
Fujian Medical University
研究点 (1)
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