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

20. mai 2021 oppdatert 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

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

151

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The median survival time in adult patients over 60 with AML diagnosis
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Celgene

Etterforskere

  • Studieleder: Montserrat Rafel, RML Advocacy, Celgene

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2018

Primær fullføring (Faktiske)

30. april 2020

Studiet fullført (Faktiske)

30. april 2020

Datoer for studieregistrering

Først innsendt

5. februar 2018

Først innsendt som oppfylte QC-kriteriene

9. februar 2018

Først lagt ut (Faktiske)

19. februar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Leukemi, Myeloid, Akutt

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