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Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain

2021年5月20日更新者：Celgene

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

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

研究概览

地位

完全的

条件

白血病，骨髓，急性

详细说明

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.

研究类型

观察性的

注册 (实际的)

151

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

西班牙
- - Madrid、西班牙、28040
    - Fundacion Jimenez Diaz
  - Madrid、西班牙、28006
    - Hospital Universitario La Princesa
  - Madrid、西班牙、28034
    - Hospital Universitario Ramón y Cajal
  - Madrid、西班牙、28040
    - Hospital Clinico San Carlos
  - Madrid、西班牙、28041
    - Hospital Universitario 12 de Octubre
  - Madrid、西班牙、28046
    - Hospital Universitario La Paz
  - Madrid、西班牙、28222
    - Hospital de Fuenlabrada
  - Madrid、西班牙、28905
    - Hospital de Getafe
- Andalucía
  - Córdoba、Andalucía、西班牙、14004
    - Hospital Univ. Reina Sofia
  - Sevilla、Andalucía、西班牙、41009
    - Hospital Universitario Virgen Macarena
- Andalucía/Cádiz
  - Jerez、Andalucía/Cádiz、西班牙、11404
    - Hospital de Jeréz
- Andalucía/Granada
  - Granada、Andalucía/Granada、西班牙、18014
    - Hospital Virgen de las Nieves
- Andalucía/Málaga
  - Málaga、Andalucía/Málaga、西班牙、29010
    - Hospital Carlos Haya
- Andalucía/Sevilla
  - Sevilla、Andalucía/Sevilla、西班牙、41013
    - Hospital Virgen Del Rocio
  - Sevilla、Andalucía/Sevilla、西班牙、41014
    - Hospital Universitario Nuestra Señora de Valme
- Aragón
  - Zaragoza、Aragón、西班牙、50009
    - Hospital Clinico Lozano Blesa
- Asturias
  - Gijón、Asturias、西班牙、33394
    - Hospital Universitario Cabueñes
  - Oviedo、Asturias、西班牙、33011
    - Hospital Universitario Central de Asturias
- Baleares
  - Palma de Mallorca、Baleares、西班牙、07120
    - Hospital Son Espases
- Castilla-León
  - Burgos、Castilla-León、西班牙、09006
    - Hospital Universitario de Burgos
  - León、Castilla-León、西班牙、24071
    - Hospital de Leon
  - Salamanca、Castilla-León、西班牙、37120
    - Complejo Hospitalario de Salamanca
  - Valladolid、Castilla-León、西班牙、47003
    - Clinico de Valladolid
- Cataluña
  - Barcelona、Cataluña、西班牙、08003
    - Hospital Del Mar
  - Lleida、Cataluña、西班牙、25198
    - Hospital Arnau de Vilanova Lleida
  - Manresa, Barcelona、Cataluña、西班牙、08243
    - Hospital de Althaia (H. Sant Juan de Deu de Manresa)
- Comunidad Madrid
  - Madrid、Comunidad Madrid、西班牙、28031
    - Hospital Infanta Leonor
- Comunidad Valenciana
  - Alicante、Comunidad Valenciana、西班牙、03010
    - Hospital General Alicante
  - Valencia、Comunidad Valenciana、西班牙、46014
    - Hospital General Universitario de Valencia
- Extremadura
  - Badajoz、Extremadura、西班牙、06080
    - Hospital Infanta Cristina
- Galicia
  - La Coruña、Galicia、西班牙、15006
    - Complejo Hospitalario Universitario de A Coruna
  - Ourense、Galicia、西班牙、32005
    - Complejo Hospitalario Universitario de Orense
- Islas Canarias
  - Las Palmas de Gran Canaria、Islas Canarias、西班牙、35010
    - Hospital Dr. Negrín
  - Santa Cruz de Tenerife、Islas Canarias、西班牙、38010
    - Hospital Nuestra Senora de Candelaria
  - Santa Cruz de Tenerife、Islas Canarias、西班牙、38320
    - Hospital Universitario Canarias
- Murcia
  - Cartagena, Murcia、Murcia、西班牙、30202
    - Hospital Santa Lucía
- Navarra
  - Pamplona, Navarra、Navarra、西班牙、31008
    - Complejo Hospitalario de Navarra
- País Vasco
  - Bilbao, Vizcaya、País Vasco、西班牙、48013
    - Hospital De Basurto
  - San Sebastián, Guipúzcoa、País Vasco、西班牙、20014
    - Hospital Universitario de Donostia
  - Vitoria、País Vasco、西班牙、01009
    - Hospital de Txagorritxu

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population will consist of approximately 150 patients over 60 with AML diagnosis, defined according to World Health Organization (WHO) 2016 criteria (presence of blasts in the bone marrow or peripheral blood equal to or greater than 20%).

Due to the observational and descriptive nature of the present investigation, the inclusion of a control group is not considered.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Patients diagnosed with AML The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
The median survival time in adult patients over 60 with AML diagnosis 大体时间：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.	Up to approximately 12 months

次要结果测量

结果测量	措施说明	大体时间
Overall Survival 大体时间：Up to approximately 12 months	The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.	Up to approximately 12 months
To describe the socio-demographic and clinical characteristics of patients 大体时间：Up to approximately 12 months	A description of the study socio-demographic and clinical variables will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as well as the measures of central and dispersion tendency of the quantitative variables. A 95% CIs will be obtained for the main variables.	Up to approximately 12 months
To describe the disease characteristics 大体时间：Up to approximately 12 months	A description of the variables that characterize the disease under study will be made. The distributions of absolute and relative frequencies of the qualitative variables will be reported, as the measures of central tendency and dispersion of the quantitative variables. A 95% CIs will be obtained for the main variables.	Up to approximately 12 months
To describe the front-line treatment strategies 大体时间：Up to approximately 12 months	The frequency distributions for the first lines of treatment will be presented, as well as the rate distribution of the most frequent treatment sequences and their evolution. It will be reported the descriptive statistics period of the first treatment lines.	Up to approximately 12 months
To assess the HRQOL evolution over time 大体时间：Up to approximately 12 months	Descriptive statistics will be reported for each of the five dimensions at every period of application of the EQ-5D, so as an overall lineal model of repeated measures for the VAS.	Up to approximately 12 months
To evaluate the impact on early mortality 大体时间：Up to approximately 8 weeks	The t-test will be used to evaluate the impact of the initial leukocyte count on early mortality (dichotomous variable minus death or not in the first 8 weeks). The stratified analysis with the same approach will be done for treatments that achieve a sufficient sample.	Up to approximately 8 weeks
To evaluate the prognostic impact on overall survival 大体时间：Up to approximately 12 months	A Cox regression model will be made considering the patient survival as a dependent variable and as possible factors the subjective variables (asthenia and HRQOL) at the time of diagnosis, the patient's general condition, and any other clinical variable that is evaluated as possible predictor. No more than 10 independent variables will be included in the model for theoretical reasons.	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. 大体时间：Up to approximately 12 months	The therapeutic approach will be collected according to the investigator clinical judgment, the score of each of the items on the Lee and GAH scales and the treatment administered tolerability assessment according to the score obtained in each scale. The weighting coefficients will be calculated using a complete multiple linear regression model and a multiple logistic regression. The optimal cut points for use as a predictive tool for treatment tolerability will be determined by using the ROC curve technique.	Up to approximately 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Celgene

调查人员

研究主任：Montserrat Rafel, RML Advocacy、Celgene

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月28日

初级完成 (实际的)

2020年4月30日

研究完成 (实际的)

2020年4月30日

研究注册日期

首次提交

2018年2月5日

首先提交符合 QC 标准的

2018年2月9日

首次发布 (实际的)

2018年2月19日

研究记录更新

最后更新发布 (实际的)

2021年5月21日

上次提交的符合 QC 标准的更新

2021年5月20日

最后验证

2021年5月1日

白血病，骨髓，急性的临床试验

Shenzhen Second People's Hospital

招聘中

中国 CML 患者停用 TKI (TFR_china)

白血病 | 骨髓的 | 慢性的 | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | 积极的

中国