Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
- Conditions
- Leukemia, Myeloid, Acute
- Registration Number
- NCT03435341
- Lead Sponsor
- Celgene
- Brief Summary
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
- Detailed Description
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:
1. 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).
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The median survival time in adult patients over 60 with AML diagnosis 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.
- Secondary Outcome Measures
Name Time Method To describe the disease characteristics 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.
To assess the HRQOL evolution over time 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.
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 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.
Overall Survival 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.
To describe the socio-demographic and clinical characteristics of patients 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.
To describe the front-line treatment strategies 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.
To evaluate the impact on early mortality 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.
To evaluate the prognostic impact on overall survival 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.
Trial Locations
- Locations (40)
Hospital de León
🇪🇸León, Castilla-León, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Andalucía/Granada, Spain
Hospital Universitario Nuestra Señora de Valme
🇪🇸Sevilla, Andalucía/Sevilla, Spain
Hospital Clínico Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital Virgen del Rocio
🇪🇸Sevilla, Andalucía/Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Andalucía, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital de Jerez
🇪🇸Jerez, Andalucía/Cádiz, Spain
Hospital Univ. Reina Sofia
🇪🇸Córdoba, Andalucía, Spain
Hospital Nuestra Señora de Candelaria
🇪🇸Santa Cruz de Tenerife, Islas Canarias, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Castilla-León, Spain
Complejo Hospitalario de Salamanca
🇪🇸Salamanca, Castilla-León, Spain
Hospital de Althaia (H. Sant Juan de Deu de Manresa)
🇪🇸Manresa, Barcelona, Cataluña, Spain
Clínico de Valladolid
🇪🇸Valladolid, Castilla-León, Spain
Hospital Dr. Negrín
🇪🇸Las Palmas de Gran Canaria, Islas Canarias, Spain
Complejo Hospitalario Universitario de A Coruña
🇪🇸La Coruña, Galicia, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Arnau de Vilanova Lleida
🇪🇸Lleida, Cataluña, Spain
Hospital Santa Lucía
🇪🇸Cartagena, Murcia, Murcia, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, País Vasco, Spain
Hospital de Getafe
🇪🇸Madrid, Spain
Hospital de Txagorritxu
🇪🇸Vitoria, País Vasco, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Carlos Haya
🇪🇸Málaga, Andalucía/Málaga, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Extremadura, Spain
Hospital Universitario Canarias
🇪🇸Santa Cruz de Tenerife, Islas Canarias, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital General Alicante
🇪🇸Alicante, Comunidad Valenciana, Spain
Complejo Hospitalario Universitario de Orense
🇪🇸Ourense, Galicia, Spain
Hospital Universitario Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital Universitario de Donostia
🇪🇸San Sebastián, Guipúzcoa, País Vasco, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Navarra, Spain
Hospital Infanta leonor
🇪🇸Madrid, Comunidad Madrid, Spain
Hospital de Fuenlabrada
🇪🇸Madrid, Spain