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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03435341
Other study ID # NDS-AML-001
Secondary ID U1111-1207-6661
Status Completed
Phase
First received
Last updated
Start date February 28, 2018
Est. completion date April 30, 2020

Study information

Verified date May 2021
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 information / eligibility

Status Completed
Enrollment 151
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital General Alicante Alicante Comunidad Valenciana
Spain Hospital Infanta Cristina Badajoz Extremadura
Spain Hospital del Mar Barcelona Cataluña
Spain Hospital de Basurto Bilbao, Vizcaya País Vasco
Spain Hospital Universitario de Burgos Burgos Castilla-León
Spain Hospital Santa Lucía Cartagena, Murcia Murcia
Spain Hospital Univ. Reina Sofia Córdoba Andalucía
Spain Hospital Universitario Cabueñes Gijón Asturias
Spain Hospital Virgen de las Nieves Granada Andalucía/Granada
Spain Hospital de Jerez Jerez Andalucía/Cádiz
Spain Complejo Hospitalario Universitario de A Coruña La Coruña Galicia
Spain Hospital Dr. Negrín Las Palmas de Gran Canaria Islas Canarias
Spain Hospital de León León Castilla-León
Spain Hospital Arnau de Vilanova Lleida Lleida Cataluña
Spain Fundación Jiménez Díaz Madrid
Spain Hospital Clínico San Carlos Madrid
Spain Hospital de Fuenlabrada Madrid
Spain Hospital de Getafe Madrid
Spain Hospital Infanta leonor Madrid Comunidad Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario La Princesa Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Carlos Haya Málaga Andalucía/Málaga
Spain Hospital de Althaia (H. Sant Juan de Deu de Manresa) Manresa, Barcelona Cataluña
Spain Complejo Hospitalario Universitario de Orense Ourense Galicia
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Son Espases Palma de Mallorca Baleares
Spain Complejo Hospitalario de Navarra Pamplona, Navarra Navarra
Spain Complejo Hospitalario de Salamanca Salamanca Castilla-León
Spain Hospital Universitario de Donostia San Sebastián, Guipúzcoa País Vasco
Spain Hospital Nuestra Señora de Candelaria Santa Cruz de Tenerife Islas Canarias
Spain Hospital Universitario Canarias Santa Cruz de Tenerife Islas Canarias
Spain Hospital Universitario Nuestra Señora de Valme Sevilla Andalucía/Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla Andalucía
Spain Hospital Virgen del Rocio Sevilla Andalucía/Sevilla
Spain Hospital General Universitario de Valencia Valencia Comunidad Valenciana
Spain Clínico de Valladolid Valladolid Castilla-León
Spain Hospital de Txagorritxu Vitoria País Vasco
Spain Hospital Clínico Lozano Blesa Zaragoza Aragón

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The median survival time in adult patients over 60 with AML diagnosis 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
Secondary Overall Survival 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
Secondary To describe the socio-demographic and clinical characteristics of patients 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
Secondary To describe the disease characteristics 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
Secondary To describe the front-line treatment strategies 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
Secondary To assess the HRQOL evolution over time 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
Secondary To evaluate the impact on early mortality 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
Secondary To evaluate the prognostic impact on overall survival 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
Secondary To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML. 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
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