Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- New therapies efficacy in terms of Overall survival
研究概览
简要总结
This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.
详细描述
This multicenter, prospective and retrospective observational study (model: case only) aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients treated at Italian GIMEMA centers. No additional procedures or visits other than those required by normal clinical practice will be required. every patient will be followed for a minimum of 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Aged 18 years or older
- •AML diagnosis according to the ELN guidelines, excluding M3
- •Signed Informed consent, if applicable
- •Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:
- •patients affected by FLT3-mutated AML treated with gilteritinib.
- •patients affected by IDH-mutated AML treated with IDH inhibitors.
- •patients affected by AML in maintenance therapy with oral azacytidine.
- •patients affected by AML treated with glasdegib.
- •patients affected by AML treated with gemtuzumab ozogamicin.
- •other novel drugs or combination for the treatment of AML approved during the study period.
排除标准
- •Patients included in interventional clinical trials.
结局指标
主要结局
New therapies efficacy in terms of Overall survival
时间窗: at 24 months
evaluation of the efficacy of the new therapies or their combinations in the real-life for AML patients in terms of Overall Survival
次要结局
未报告次要终点