Characterization of Infectious Events and Their Impact on Survival in Patients with Acute Myeloid Leukemia Treated with Intensive Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Description of the incidence, nature and complications engendered by the occurrence of infectious events during intensive management for AML.
研究概览
简要总结
Despite therapeutic advance in acute myeloid leukemia (AML), the prognosis remains poor, with an overall survival (OS) of 30% at 5 years [1, 2]. Treatment of 1st-line AML in patients under 75 years of age is based on intensive chemotherapy (IC) followed by allogeneic transplantation (hematopoietic stem cell transplantation, HSCT) [3]. Following its administration, a phase known as aplasia ensues, during which patients are severely immunocompromised. This period of aplasia therefore carries a very high risk of infectious events, despite management in protected areas and infectious prophylaxis. Infectious problems remain one of the leading causes of mortality in the initial phase of AML treatment [4]. The incidence of sepsis, the microorganisms involved and the complications arising from infectious episodes during chemotherapy remain poorly described, as do their long-term prognostic consequences for these patients [5,6].
Moreover, there is a "dogma" among hematologists dealing specifically with AML that intensive chemotherapy during which there are no infectious events is often a sign of non-response. Although this "popular" belief has never been verified prospectively or even retrospectively, it is based on the observation of many generations of clinicians. This belief suggests that immune stimulation during aplasie could promote remission by inducing an anti-leukemic immune response. Furthermore, numerous cases of "spontaneous" remission (i.e. in AML patients receiving no active treatment) following infections or highly immune-stimulating events have been reported in the literature [7-10].
It might therefore be hypothesized that infectious events occurring during the post-intensive chemotherapy aplasia phase for AML could favor the achievement of remission by nonspecific immune stimulation.
The aim of this study is to describe the incidence and type of septic episodes occurring in patients undergoing intensive treatment for acute myeloid leukemia, and to assess the impact of these episodes on patient prognosis, notably via the risk of relapse and long-term survival.
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
- •Patients with acute myeloid leukemia (AML)
- •Age over 18 years
- •Treatment with "intensive" chemotherapy (combination of aracytin and an anthracycline)
- •Date of diagnosis of acute myeloid leukemia between 01/01/2015 and 31/12/2021
- •Treatment received at Hospices Civils de Lyon (HCL)
排除标准
- •Patients with acute promyelocytic leukemia (AML 3)
- •Treatment with "non-intensive" chemotherapy (i.e. azacytidine)
- •Death before first post-chemotherapy bone marrow assessment
- •No computerized data available
- •Follow-up at a center other than HCL
结局指标
主要结局
Description of the incidence, nature and complications engendered by the occurrence of infectious events during intensive management for AML.
时间窗: through study completion, during 3 mounths
Analysis of the number, type, and complications of infectious events observed during the induction and consolidation phases of intensive management for AML.
次要结局
未报告次要终点