NCT06686173尚未招募不适用
The Effect of the Parous Female and Young Male Donor on the Outcomes of GVHD Prophylaxis Underwent the Combined Treatment of ATG and PTCy for Haplo-HSCT: a Prospective, Multi-center, Cohort Study
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 114 人开始时间: 2025年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 主要终点
- RFS
研究概览
简要总结
This is a prospective, multicenter, cohort study. The high-risk, relapse and refractory AML patients were enrolled in this study. And the goal of this study is to study the effect of the parous female donor and young male donor on the outcomes of graft-versus-host disease (GVHD) prophylaxis underwent the combination of ATG and PTCy for haploidentical peripheral blood stem cell transplantation
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myeloid leukemia was diagnosed according to the 2016ELN criteria with any of the following:
- •ELN prognostic stratification high-risk group (see Appendix for criteria)
- •Non-remission (NR) AML: including primary refractory AML and NR patients after relapse.
- •Patients must have a suitable hematopoietic stem-cell donor.
- •Patients had to have a qualified haploidentical young male (≤30 years old) or female with a history of pregnancy;
- •Related donors had to be related donors matched 5/10-7/10 for HLA-A, -B, -C, -DQB1 and -DRB1
- •All the enrolled patients received a unified GVHD prevention regimen based on ATG and PTCy
排除标准
- •Intermediate-low risk AML patients (ELN criteria);
- •Patients with extramedullary active lesions at the time of transplantation;
- •Haploidentical collateral donors;
- •Patients who refused allogeneic hematopoietic stem cell transplantation;
结局指标
主要结局
RFS
时间窗: one year
1-year RFS after transplantation
次要结局
未报告次要终点
研究者
Xianmin Song, MD
professor of medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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