此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

2015年10月5日更新者：Kiadis Pharma

An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

178

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

加拿大
- Ontario
  - Hamilton、Ontario、加拿大、L8N 3Z5
    - Hamilton Niagara Regional Haemophilia Centre
- Quebec
  - Montreal、Quebec、加拿大、H1T 2M4
    - Maisonneuve-Rosemont Hospital
德国
- - Würzburg、德国、97080
    - Universitätsklinikum Würzburg
比利时
- - Brugge、比利时、8000
    - Algemeen Ziekenhuis Sint-Jan
  - Brussels、比利时、1000
    - Institut Jules Bordet
  - Leuven、比利时、3000
    - Universitair Ziekenhuis Gasthuisberg
美国
- Ohio
  - Columbus、Ohio、美国、43210
    - Ohio State University Comprehensive Cancer Center
英国
- - London、英国、W12 OHS
    - Hammersmith Hospital
荷兰
- - Maastricht、荷兰、6229 HX
    - Academisch Ziekenhuis Maastricht

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.

描述

Inclusion Criteria:

Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in remission at the time of the transplantation
- Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
- Myelodysplastic syndrome (MDS)
Patient received any of the following transplantations:
- Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
- Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
- Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
Male or female, age ≥ 18, ≤ 65 years.

Exclusion Criteria:

Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
HAPLO group Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013
MUD group Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012
MMUD group Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012
UCB group Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Transplant-related mortality 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation

次要结果测量

结果测量	大体时间
Overall survival 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation
Incidence of acute and chronic graft versus host disease 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation
Progression-free survival 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation
Severity of acute and chronic graft versus host disease 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation
Relapse-related mortality 大体时间：Up to 12 months after the transplantation	Up to 12 months after the transplantation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kiadis Pharma

调查人员

学习椅：Jeroen Rovers, MD、Kiadis Pharma

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年9月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2014年7月10日

首先提交符合 QC 标准的