NCT05103995已完成不适用
Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation
First Affiliated Hospital of Zhejiang University2 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 510
- 试验地点
- 2
- 主要终点
- 5-year Overall Survival
研究概览
简要总结
the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation
详细描述
The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects or their legal representatives signed the informed consent before the clinical study.
- •Subjects aged 15-70 years.
- •Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation
- •Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation
- •Subjects with ECoG score of 0-2.
排除标准
- •1.Patients have suitable HLA identical sibling donor
- •Patients with severe liver and kidney function (alanine aminotransferase > 2.5 times of the upper normal limit, serum creatinine > 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction < 50%, severe obstructive or restrictive ventilation dysfunction);
- •Patients with active infection;
- •patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation;
- •Subjects with ECoG score > 2;
- •Patients with secondary tumor;
- •Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.
结局指标
主要结局
5-year Overall Survival
时间窗: 5 year
5-year Overall Survival
次要结局
- the 5-year cumulative incidence of graft failure(5-year)
- 5-year cumulative incidence of chronic graft versus host disease(5 year)
- 365-day blood transfusion requirements(365 day)
- cumulative incidence of blood transfusion independence within 60 days after transplantation(60 day)
- 5-year Non-relapse mortality(5 year)
- 28-day cumulative incidence of neutrophils engraftment(28 day)
- 28-day cumulative incidence of platelets engraftment(28 day)
- the 5-year cumulative incidence of poor graft function the incidence of poor graft function(5 year)
- 100-day cumulative incidence of acute graft versus host disease(100-day)
研究者
Yi Luo
Principal Investigator
First Affiliated Hospital of Zhejiang University
研究点 (2)
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