Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,996
- 试验地点
- 29
- 主要终点
- Disease Free Survival (DFS)
研究概览
简要总结
Retrospective, observational, multicentre, spontaneous, non-interventional study This study will evaluate all consecutive patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.
详细描述
The age of patients' population is increasing every year, as the life expectancy. Thus, the incidence and prevalence of hematological cancers is increasing. In particular, acute leukemias and myelodysplastic syndromes are the most frequent diseases of the hematopoietic system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for these diseases, and the number of allo-SCTs in the elderly is currently in progressive growth. This is partially due to the improvement of the allo-SCT procedure over the years, with the amelioration of donor selection, Human Leukocyte Antigen typing, graft versus host disease (GVHD) and infections prophylaxis and treatment.
Nevertheless, there is still an unmet clinical need, represented by the lack of extensively and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, the investigators planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the Gruppo Italiano Trapianti di Midollo Osseo transplant activity of the last 17 years. This study will help us in designing future prospective trials, including a comprehensive geriatric assessment of frailty, in order to address to allo-SCT those elderly who have the highest probability to achieve the best long term outcome with the lowest transplant-related mortality and morbidity.
For patients submitted to more than one transplant, the first transplant will be considered only and the record of these patients will be derived from the Gruppo Italiano Trapianti di Midollo Osseo database and the European group for Blood and Marrow Transplantation database (Promise), where all the transplant activity is regularly recorded.
Primary objective is description of the patients' population. This endpoint will particularly focus on the changing, over the years, of the clinical and hematological characteristics of elderly patients submitted to allo-SCT.
Secondary objectives are: description of the transplants' characteristics, such as the conditioning regimens and the GVHD prophylaxis, description of acute and chronic graft versus host disease (GVHD) incidence and treatment, description of overall survival (OS), disease-free survival (DFS), transplant related mortality (TRM) and relapse risk (RR).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic transplantation from 2000 to 2017 (for patients submitted to more than one transplant, only the first transplant will be considered)
- •Informed consent
排除标准
- •Absence of informed consent
结局指标
主要结局
Disease Free Survival (DFS)
时间窗: These outcome measures will be assessed at 5 years from transplant
DFS is defined as the probability of being alive free of disease at any point in time.
Transplant Related Mortality (TRM)
时间窗: These outcome measures will be assessed at 5 years from transplant
TRM was defined as death due to any transplantation-related cause other than disease relapse
Overall Survival (OS)
时间窗: These outcome measures will be assessed at 5 years from allo-SCT.
is defined as the time from transplant to the date of death due to any cause or to the last date the patient was known to be alive (censored observation) or to the date of the data cut-off for final analysis
Relapse risk (RR)
时间窗: These outcome measures will be assessed at 5 years from transplant.
The relative risk (RR) or risk ratio is the ratio of the probability of an outcome in an exposed group to the probability of an outcome in an unexposed group.
次要结局
- Acute Graft-versus-Host Disease(These outcome measures will be assessed at 100 days from transplant)
- Chronic Graft-versus-Host Disease(These outcome measures will be assessed at 5 years from transplant)