Italian Non-Interventional Study of FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 33
- 主要终点
- percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive;
研究概览
简要总结
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations
详细描述
This is an observational study involving a retrospective and prospective collection of clinical and molecular data. Patients will follow their regular diagnostic and clinical practice. Thus, no additional procedure/blood withdrawal will be performed.
The study will be conducted as follows:
- Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
- Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.
For patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.
The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive;
时间窗: up to 24 months
description of how the FLT3 mutational status changes during the course and management of the disease
percentage of patients FLT3 positive at diagnosis who relapse FLT3 negative
时间窗: up to 24 months
description of how the FLT3 mutational status changes during the course and management of the disease
次要结局
- objective overall response rate (ORR)(up to 24 months)
- disease-free survival (DFS)(up to 24 months)
- Percentage of AML patients with specific types of FLT3 mutations(up to 24 months)
- retrospective collection of surrogate measures of QoL(up to 24 months)
- overall survival (OS)(up to 24 months)
- distribution of specific FLT3 mutations in AML patients(up to 24 months)
- frequency of the different methods used to evaluate (Minimal residual disease) MRD(up to 24 months)
- transplantation percentage(up to 24 months)
- evaluation of modifications in terms of quality of life (QoL) of patients with FLT3 mutated AML(up to 24 months)
- FLT3-ITD allelic ratio(up to 24 months)