Observational Study on APL-like Subset Within NPM1-mutated Acute Myeloid Leukemia: a Distinct Phenotypic Signature Correlating With Early-onset Vascular Complications. ACTIVATE (APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of early vascular events
研究概览
简要总结
This is a multicenter observational study with a retrospective and a prospective cohort investigating clinically and biologically the APL-like subset as a potential predictor of coagulopathy and susceptibility to early vascular events.
详细描述
This is a multicenter observational study with a retrospective and a prospective cohort investigating clinically and biologically the APL-like subset as a potential predictor of coagulopathy and susceptibility to early vascular events.
Participating Centers will identify NPM1-mutated patients eligible for enrollment. The immune-phenotypic data will be evaluated to define a specific signature to be applied for the identification of APL-like AML.
All patients will be followed for a minimum of 12 months until the study closure.
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 de novo AML, untreated, newly diagnosed, according to WHO/ICC 2022 criteria from January 2015 onwards.
- •Presence of NPM1 mutation.
- •Availability of immunophenotypic characterization at diagnosis
- •Age >= 18 years
- •Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)
排除标准
- •No specific exclusion criteria are provided once eligibility criteria are met.
研究组 & 干预措施
APL-like
NPM1 AML patients identified as APL-like cohort
干预措施: observation of incidence of early vascular events (Other)
Non APL-like
NPM1 AML patients identified as no APL-like cohort
干预措施: observation of incidence of early vascular events (Other)
结局指标
主要结局
Incidence of early vascular events
时间窗: 30 days from diagnosis
Evaluation of the incidence of early vascular events (haemorrhagic and/or thrombotic) in the APL-like and non-APL-like subsets.
次要结局
未报告次要终点