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临床试验/NCT07598838
NCT07598838进行中(未招募)不适用

Multicenter Retrospective Observational Study to Verify the Application of SIE/SIES/GITMO FITNESS CRITERIA to Guide Therapeutic Choice in Elderly Patients With Acute Myeloid Leukemia in Light of the Availability of New Drugs - AML FITNESS

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 725 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
725
试验地点
1
主要终点
overall survival according to fitness categories and treatment received

研究概览

简要总结

The study aims to evaluate the outcome of patients (overall survival) who received treatments commensurate with the proposed "Fitness" parameters compared to that of patients whose treatment differed either in the direction of greater or lesser aggressiveness than that proposed (evaluation of survival through Kaplan-Meier analysis and comparison with the log-rank test).

详细描述

Evaluate adherence to SIE/SIES/GITMO criteria in therapeutic choice: assess the treatment actually received by the different patient groups and any deviations from those proposed (descriptive statistics)

  • Evaluate whether the SIE/SIES/GITMO criteria are still current after the introduction of new drugs (descriptive statistics)
  • Evaluate the treatment actually received by the different patient groups and any deviations from those proposed
  • Evaluate the possibility of potentially identifying new criteria to better define fitness categories in light of the therapy actually administered to the patient (descriptive statistics)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute Myeloid Leukemia Diagnosis no Acute Promyelocytic Leukemia aged more than 65 years

排除标准

  • 未提供

结局指标

主要结局

overall survival according to fitness categories and treatment received

时间窗: "From enrollment to the end of treatment at 12 months"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erika Borlenghi

Dr.

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

研究点 (1)

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