Correlation Between the Pre-transplantation Lymphocyte Count, Administered Dose of Thymoglobulin and Graft Versus Host Disease (GVHD) in Pediatric Recipients of Hematopoietic Stem Cells Transplantation: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Development of GVHD according to lymphocyte/ATG ratio
研究概览
简要总结
Despite increasing success rate in hematopoietic stem cell transplantation (HSCT) control of graft versus host disease (GVHD) remains a significative burden in mortality and morbidity. A lot of strategies could lower the incidence and gravity of the disease and immunosuppressive treatment as GVHD prophylaxis still represent the main method.
Although immunosuppressive treatment showed a good effect on GVHD mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of HSCT recipient. Using anti thymocyte globulin (ATG) as GVHD prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on GVHD. Biological effect of ATG lead to a dose- related delay in all class of T-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mg/kg due to the more important burden of GVHD in HSCT adult population. As for other treatment in HSCT conditioning we would like to study a personalized approach for ATG treatment: some studies focus on tuning of ATG dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients, even though same age and same stem cell source.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of the patients between 0 and 17
- •Diagnosis of hematological or oncological disease undergoing allogeneic bone marrow transplantation
- •Patients undergoing myeloablative conditioning
- •Patients that received ATG as GVHD prophylaxis
- •Patients whose consent has already been acquired for the processing of data for research purposes
- •Minimum follow-up of 12 months
排除标准
- •Bacterial and / or fungal infection present at the time of bone marrow transplantation
- •Use of Thymoglobulin in the 3 months prior to transplantation
- •Allergy and / or intolerance to the active substances or excipients contained in Thymoglobulin
结局指标
主要结局
Development of GVHD according to lymphocyte/ATG ratio
时间窗: 24 months after transplant
Differences in the frequency of GVHD according to the two exposure's groups (lymphocyte/ATG ratio \<0.01 vs \>0.01). Adjustment for potentially associated variables (e.g., dose of drug actually received by patients, age of patients, type of conditioning, underlying disease, type of donor) will be carried out
次要结局
- Entity of GVHD according to lymphocyte/ATG ratio(24 months after transplant)
- Number of episodes of fungal infections during the post transplant period according to lymphocyte/ATG ratio(24 months after transplant)
- Number of episodes of sepsis during the post-transplant period according to lymphocyte/ATG ratio(24 months after transplant)
- Transplant related mortality according to lymphocyte/ATG ratio(24 months after transplant)
- Incidence of Graft Failure according to lymphocyte/ATG ratio(24 months after transplant)
- Number of episodes of viral reactivations during the post transplant period according to lymphocyte/ATG ratio(24 months after transplant)
