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

20 mai 2021 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Leucémie, myéloïde, aiguë

Description détaillée

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:

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).
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.

Type d'étude

Observationnel

Inscription (Réel)

151

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

60 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
The median survival time in adult patients over 60 with AML diagnosis Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Overall Survival Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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. Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Celgene

Les enquêteurs

Directeur d'études: Montserrat Rafel, RML Advocacy, Celgene

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 février 2018

Achèvement primaire (Réel)

30 avril 2020

Achèvement de l'étude (Réel)

30 avril 2020

Dates d'inscription aux études

Première soumission

5 février 2018

Première soumission répondant aux critères de contrôle qualité

9 février 2018

Première publication (Réel)

19 février 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 mai 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 mai 2021

Dernière vérification

1 mai 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

NDS-AML-001
U1111-1207-6661 (Identificateur de registre: UTN)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Leucémie, myéloïde, aiguë

Shenzhen Second People's Hospital

Recrutement

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Leucémie | Myéloïde | Chronique | BCR-ABL (Breakpoint Cluster Region-abelson Murine Leukemia) | Positif

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