Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
NCT ID: NCT03435341
Last Updated: 2021-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
151 participants
OBSERVATIONAL
2018-02-28
2020-04-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients diagnosed with AML
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Montserrat Rafel, RML Advocacy
Role: STUDY_DIRECTOR
Celgene
Locations
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Hospital de Jerez
Jerez de la Frontera, Andalucía/Cádiz, Spain
Hospital Virgen de las Nieves
Granada, Andalucía/Granada, Spain
Hospital Carlos Haya
Málaga, Andalucía/Málaga, Spain
Hospital Virgen del Rocio
Seville, Andalucía/Sevilla, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, Andalucía/Sevilla, Spain
Hospital Univ. Reina Sofia
Córdoba, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital de Basurto
Bilbao, Vizcaya, Basque Country, Spain
Hospital Universitario de Donostia
San Sebastián, Guipúzcoa, Basque Country, Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital de León
León, Castille and León, Spain
Complejo Hospitalario de Salamanca
Salamanca, Castille and León, Spain
Clínico de Valladolid
Valladolid, Castille and León, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Arnau de Vilanova Lleida
Lleida, Catalonia, Spain
Hospital de Althaia (H. Sant Juan de Deu de Manresa)
Manresa, Barcelona, Catalonia, Spain
Hospital Infanta leonor
Madrid, Comunidad Madrid, Spain
Hospital Infanta Cristina
Badajoz, Extremadura, Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña, Galicia, Spain
Complejo Hospitalario Universitario de Orense
Ourense, Galicia, Spain
Hospital Santa Lucía
Cartagena, Murcia, Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Navarre, Spain
Hospital Universitario Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Alicante
Alicante, Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital de Fuenlabrada
Madrid, , Spain
Hospital de Getafe
Madrid, , Spain
Countries
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Other Identifiers
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U1111-1207-6661
Identifier Type: REGISTRY
Identifier Source: secondary_id
NDS-AML-001
Identifier Type: -
Identifier Source: org_study_id
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