NCT02188290已完成不适用
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
Kiadis Pharma9 个研究点 分布在 6 个国家目标入组 178 人开始时间: 2014年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 9
- 主要终点
- Transplant-related mortality
研究概览
简要总结
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.
结局指标
主要结局
Transplant-related mortality
时间窗: Up to 12 months after the transplantation
次要结局
- Relapse-related mortality(Up to 12 months after the transplantation)
- Overall survival(Up to 12 months after the transplantation)
- Incidence of acute and chronic graft versus host disease(Up to 12 months after the transplantation)
- Progression-free survival(Up to 12 months after the transplantation)
- Severity of acute and chronic graft versus host disease(Up to 12 months after the transplantation)
研究者
研究点 (9)
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