跳至主要内容
临床试验/NCT04869254
NCT04869254已完成不适用

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

IRCCS Burlo Garofolo1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2000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
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

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)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验