Validation of the Use of the "ELN 2022" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017
研究概览
简要总结
"In daily clinical practice, 2022 ELN guidelines were used to predict response to conventional treatment and to guide the need for allogenic stem cell transplantation. But, the team has to underline that ELN guidelines are mainly reflective of relatively young Caucasian patients. Few studies have compared 2017 and 2022 ELN in ethnicity cohorts to evaluate the potential prognostic value of this new criteria in these types of population. For example, with the 2022 ELN guidelines, the disease-free surviva) and the overall survival of African American < 60 y.o were not statistically different between intermediate and adverse groups (p=0.30, p=0,46). There were not a significant difference between favorable and intermediate groups in DFS (p=0.42, p=0.42) respectively in African American and Hispanic patients or in OS (p=0.67) in Hispanic patients. Is the 2022 ELN applicable to all ethnic subgroups? To date, no studies have examined and validated its applicability in Middle Eastern or North Coast of Africa (MENAFC) patients."
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML
- •At least 18 yo
- •MENAFC (Middle East ern of North Coast of Africa) patients with HLA HLA > 50%
- •ECOG performance status of 0,1,2,3"
排除标准
- •Acute promyelocytic leukemia
- •Patients alive at the start of the study who did not receive study information or who objected to the collection of data"
结局指标
主要结局
Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017
时间窗: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Patient alive or not. Patient alive at last follow-up were censored.
次要结局
- Safety and tolerance(Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025)
- Relapse free survival before alloHSCT(Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025)
- Risk group according to 2017 and 2022 ELN(At the diagnosis)
- Complete remission rates(Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025)