Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
研究概览
简要总结
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
详细描述
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B Ph-neg or T ALL at onset
- •Age > 18 yr at the time of the study
- •Signature informed consent
排除标准
- •Patients with Ph-pos ALL
- •Patients with relapsing ALL
- •Patients with B/T lymphoblastic lymphoma
结局指标
主要结局
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
时间窗: 16 weeks
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
次要结局
- - Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted(16 weeks)
- - Incidence of IFI in patients with Ph-neg ALL during induction in relation to age(16 weeks)
- - Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI(16 weeks)
- - Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)(16 weeks)
- Patient mortality rate in Ph-neg ALL patients with IFI(16 weeks)
- - Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia(16 weeks)
研究者
Chiara Cattaneo
Head of Hematology inpatient unit
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia