Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 2,100
- 试验地点
- 8
- 主要终点
- Non-relapse mortality
研究概览
简要总结
Via a prospective non-interventional study clinical outcome of patients with - and without - history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in terms of non-relapse mortality overall mortality and fungal infectious morbidity.
Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of pre-existing IA vs. no pre-existing IA.
Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%) than patients without pre-existing IA.
Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.
Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of probable or proven invasive aspergillosis: this cohort includes also the patient with a history of possible mycosis not documented microbiologically.
详细描述
Background & Rationale. In patients with pre-existing invasive aspergillosis allo-HSCT is feasible without progression of fungal infection. However, the influence of invasive pulmonary aspergillosis (IA) on transplant related complications and on long term survival has not been investigated in a larger patient cohort under current conditions.
Recently the IDWP and ALWP performed a retrospective analysis on the impact of preexisting aspergillosis on allo-HSCT outcome.2 In summary, there was a trend towards impaired outcome of allo-HSCT in patients with prior IA but there was no significant impact on important allo-HSCT transplant outcomes, such as survival, GVHD and relapse. The data suggest that a history of IA should not generally be considered a contraindication for allo-HSCT. To be able to more precisely investigate the impact of IA on allo-HSCT, a non-interventional prospective study is needed.
Primary objective:
To determine if pre-existing IA influences non-relapse mortality after allo-HSCT
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First allo-HSCT
- •Acute leukaemia or MDS
- •Received stem cell grafts
排除标准
- •History, in the 6 months preceding HSCT, or documented presence of Invasive candida or mould infections other than IA (Mucor, Fusariosis).
- •(Previous history Candida infection, both superficial or systemic, is not an exclusion criteria if the patient has completely recovered from it at HSCT).
结局指标
主要结局
Non-relapse mortality
时间窗: 1 year
One year non-relapse mortality cumulative incidence
次要结局
- Relapse free survival(1 year)
- Incidence and severity of Graft versus Host Disease(1 year)
- Incidence of relapse(1 year)
- Overall survival(1 year)
- Status of Invasive Aspergillosis(1 year)