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

20 maj 2021 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

151

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The median survival time in adult patients over 60 with AML diagnosis
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Celgene

Utredare

  • Studierektor: Montserrat Rafel, RML Advocacy, Celgene

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 februari 2018

Primärt slutförande (Faktisk)

30 april 2020

Avslutad studie (Faktisk)

30 april 2020

Studieregistreringsdatum

Först inskickad

5 februari 2018

Först inskickad som uppfyllde QC-kriterierna

9 februari 2018

Första postat (Faktisk)

19 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 maj 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 maj 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NDS-AML-001
  • U1111-1207-6661 (Registeridentifierare: UTN)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Leukemi, Myeloid, Akut

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