Observational, Electronic Database With a Prospective Phase and Retrospective Phase for the Follow up of the ATG_FamilyStudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- cumulative incidence of cGVHD
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (HSCT) is capable of definitive cure of acute leukemias. The most important post-transplant complication is graft vs host disease (GVHD) which can be substantially decreased by the addition of anti-T lymphocyte globulin (ATG-Grafalon) to the standard GVHD prophylaxis (cyclosporin and methotrexate) without any increase in relapses and infections (Kroger et al NEJM 2016, ClinicalTrials.gov number, NCT00678275). In the ATG_familystudy (prospective, randomised, multicenter study) a decrease in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10 mg/kg for three days ,from day -3 to -1) to the standard GVHD prophylaxis in the setting of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of 2 years from transplant. The investigators would like to evaluate the longer term follow up of this study.
详细描述
In the ATG_familystudy (prospective, randomised, multicenter study) a decrease in the incidence of chronic GVHD (from 67.8% to 32.2%) was observed after the addition of ATG (10 mg/kg for three days from day -3 to -1) to the standard GVHD prophylaxis in the setting of acute leukemias in any remission, receiving peripheral blood stem cells from an HLA identical sibling donor after myeloablative preparative regimen. In particular, the GVHD extensive form was reduced from 52.4% to 7.6%. The study has been closed in 2014 with a minimum follow up of 2 years from transplant.
The primary endpoint is the creation of a multicenter electronic database with data of the patients previously enrolled in the ATG_family study, NCT00678275; the data collection will last ten years. Schedule of the follow-up will have be until death and will be stopped any time if patient will retire the consent.
The database will allow to evaluate:
- Long term mortality of enrolled patients, with and without GVHD
- Long term relapse after allogeneic HSCT in acute leukemia patients
- Prognostic factors in the overall population and according to the randomization arm
- Recovery of working activity
Study design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •all patients already enrolled in the ATG_family_study (NCT00678275), and published by Kroger N et al. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N Engl J Med 2016;374:43-53
- •informed consent given
排除标准
- 未提供
结局指标
主要结局
cumulative incidence of cGVHD
时间窗: cumulative incidence of cGVHD through study competition, an average of 24 months
cumulative incidence according to Fine and Gray method, labeling death before the event of interest as a competing risk.
次要结局
- Overall survival after allogeneic stem cell transplant(overall survival through study competition, an average of 24 months)
研究者
Francesca Bonifazi, MD
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna