Prospective Observational Study on Overall Survival and Quality of Life in Patients Older Than 60 Years With Acute Myeloid Leukemia Diagnosis in Spain, Treated According to Standard Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 151
- 试验地点
- 40
- 主要终点
- The median survival time in adult patients over 60 with AML diagnosis
研究概览
简要总结
Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of standard clinical practice.
The study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up
详细描述
Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:
- Recruitment period: One year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
- Follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
The patient clinical history and the study´s questionnaires will be the source documents. The study will be carried out in the facilities of the Hematology and Hemotherapy Services of the participating centers, collecting the conditions of medical action according to the standard clinical practice.
Being an observational study, no intervention out of standard clinical practice will be performed. No additional diagnostic or treatment procedures will be applied for the patients.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of both sexes, aged 65 years and older.
- •Any race, nationality or socioeconomic status.
- •AML (defined according to WHO 2016 criteria de novo, with previous hematological history or secondary.
- •Diagnosis date later than 1st November 2017 and later than each center activation date.
- •Patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative).
- •Having given informed consent prior to start the data collection.
排除标准
- •Inability to understand the informed consent form.
- •AML previously treated (with or without HSCT).
- •Acute promyelocytic leukemia.
- •Participation in a clinical trial that includes first-line treatment for AML.
- •Do not grant consent.
结局指标
主要结局
The median survival time in adult patients over 60 with AML diagnosis
时间窗: Up to approximately 12 months
The overall survival will be calculated, defined as the time from the diagnosis date to the death date from any reason. In patients who have not died (censored) at the time of data collection, it will be considered the available time to the last control (or last date). The overall survival will be analyzed using the Kaplan-Meier method, providing the median at 95% CI. Patients who undergo a hematopoietic transplant will be censored at that time.
次要结局
- To describe the disease characteristics(Up to approximately 12 months)
- To assess the HRQOL evolution over time(Up to approximately 12 months)
- To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML.(Up to approximately 12 months)
- Overall Survival(Up to approximately 12 months)
- To describe the socio-demographic and clinical characteristics of patients(Up to approximately 12 months)
- To describe the front-line treatment strategies(Up to approximately 12 months)
- To evaluate the prognostic impact on overall survival(Up to approximately 12 months)
- To evaluate the impact on early mortality(Up to approximately 8 weeks)