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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435341
• Other study ID #: NDS-AML-001
• Secondary ID: U1111-1207-6661
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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