Donor-specific Anti-HLA Antibodies (DSAS) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation From Mismatched Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 912
- 试验地点
- 25
- 主要终点
- Role of DSAs on neutrophils and platelets engraftment
研究概览
简要总结
Retrospective observational multicentric, spontaneous non-interventional non-pharmacological Italian study. The primary objective is analysis of Anti-HLA antibodies and DSAs searching and monitoring activities in haematological adult and paediatric patients undergoing allo-HSCT from January 2014 to June 2017. This study will evaluate approximately 1000 subjects (with competitive enrolment) from GITMO investigational centers.
详细描述
The aim of the study is to evaluate, retrospectively, the activity of the Italian Centres in the search for donor-specific anti-HLA antibodies (DSAs) in patients undergoing allogeneic hematopoietic stem cell transplantation from mismatched donors and the strategy of treatment employed in case of DSAs positivity. Moreover, the study aims are to evaluate the role of DSAs on the engraftment. The interest in the study arises from the absence of knowledge on the MFI cut-off value clinically significant, and from the absence of the knowledge on the role of DSAs against each HLA locus on the engraftment and post-transplant survival. Furthermore, shared desensitization protocols and common donor selection strategies are lacking.
In recent years, with the increase of haploidentical and mismatched unrelated donor transplants, is also increasing the interest for DSAs at the time of HSCT, considering their potential role on graft failure by cell-mediated or antibody-mediated mechanisms.
Having a picture of the policy about DSAs management in Italian Transplant Centers, and of the indications reported by the Histocompatibility and Immunogenetic Laboratories, will allow to define, in collaboration with GITMO / AIBT, a consensus strategy. This strategy could be the platform for prospective studies.
The study involves the enrolment of patients (adults and paediatrics) undergoing mismatched allogeneic transplant, in the period 2014-2017 regardless of the source of stem cells and the search for DSAs. The sample size includes all the transplants recorded in the Gruppo Italiano Trapianti di Midollo Osseo and European group for Blood and Marrow Transplantation database.
Primary objectives are two: the analysis of Anti-HLA antibodies and DSAs searching and monitoring activities in haematological patients undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) performed by Histocompatibility and Immunogenetic Laboratories in collaboration with Italian transplant centres and assess to the impact of DSAs on neutrophil and platelet engraftment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who underwent mismatched allogeneic transplantation, from January 2014 to June 2017
- •signed the informed consent
排除标准
- •Absence of consent Written information
结局指标
主要结局
Role of DSAs on neutrophils and platelets engraftment
时间窗: 28 days from allogeneic hematopoietic stem cell transplantation
Time to reach an absolute neutrophil count \> 0.5 109/L from day of HSCT. Neutrophil recovery end-point will be defined as the first of 3 consecutive days with an absolute neutrophil count \> 0.5 x109/L. Time engraftment of platelet count will be defined as PTLS \>20.9 x 109/L without transfusion requirements for at least 5 days.
Analysis of the monitoring practice of DSAs
时间窗: 6 months from allogeneic hematopoietic stem cell transplantation
The variables that will be collected are: Type of transplant in which the search for DSAs is carried out, Laboratory methods used, Positivity cut-off used, Donor selection criteria if DSAs present, Desensitization protocol employed
Graft failure
时间窗: 28 days from allogeneic hematopoietic stem cell transplantation
graft failure is defined as peripheral blood ANC \< 0.5 × 109/L by after allogeneic hematopoietic stem cell transplantation without evidence of relapse
次要结局
未报告次要终点