Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)
研究概览
简要总结
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.
详细描述
The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Period of HSCT: January 1st 2013 to December 31th
- •GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
- •Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.
排除标准
- •Cord blood HSCT.
- •Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
- •Alentuzumab as GvHD prophylaxis.
- •Sirolimus as GvHD prophylaxis.
- •HIV positive, HVC, HVB active or latent at HSCT.
- •CMV prophylaxis with letermovir.
结局指标
主要结局
Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)
时间窗: 1 year
Median time to CMVi
时间窗: 1 year
Overall survival by day +100, +180 and +365
时间窗: 1 year
Overall mortality by day +100, +180 and +365
时间窗: 1 year
Cumulative incidence of PET-CMVi by day +100, +180 and +365.
时间窗: 1 year
Non-relapse mortality by day +100, +180 and +365
时间窗: 1 year
次要结局
- Incidence of CMVi recurrent episodes(1 year)
- CMV disease(1 year)
- CMV indirect effects incidence(1 year)
- Cumulative incidence of moderate-severe cGvHD(1 year)
- CMV direct mortality(1 year)
- Cumulative incidence of II-IV aGvHD(1 year)