Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acute Graft-Versus-Host Disease
研究概览
简要总结
Aim of this study is to investigate the effect of early administration of anti-thymocyte globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem cell transplantation.
详细描述
Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are increasingly used in patients lacking a matched donor, but the optimal strategy needs to be defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.
排除标准
- •A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.
研究组 & 干预措施
ATG/LD-PTCy group
Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center
干预措施: ATG-LDPTCy (Drug)
结局指标
主要结局
Acute Graft-Versus-Host Disease
时间窗: From the date of transplantation until 365 days after transplantation
Incidence of acute GVHD ≥ grade 2
Emgraftment Rate
时间窗: From the date of transplantation until 28 days after transplantation
cumulative incidence of donor-dominant engraftment by day 28 (by case)
Time to Engraftment
时间窗: From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays
median time to neutrophil engraftment
Chronic Graft-Versus-Host Disease
时间窗: From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation
Incidence of moderate to severe chronic GVHD
次要结局
- Rate of CMV infection(From the date of transplantation until 365 days after transplantation)
- Rate of Hemorrhagic Cystitis(From the date of transplantation until 365 days after transplantation)
研究者
KeonHee Yoo
Professor
Samsung Medical Center