Clinical trial NCT03435341: Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid, Acute
Keywords: Acute Myeloid Leukemia (AML)
Observational
Standard Clinical Practice
Survival
Tolerability
Spain
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 151
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The median survival time in adult patients over 60 with AML diagnosis
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to approximately 12 months
measure: To describe the socio-demographic and clinical characteristics of patients
timeFrame: Up to approximately 12 months
measure: To describe the disease characteristics
timeFrame: Up to approximately 12 months
measure: To describe the front-line treatment strategies
timeFrame: Up to approximately 12 months
measure: To assess the HRQOL evolution over time
timeFrame: Up to approximately 12 months
measure: To evaluate the impact on early mortality
timeFrame: Up to approximately 8 weeks
measure: To evaluate the prognostic impact on overall survival
timeFrame: Up to approximately 12 months
measure: To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML.
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Jerez
country: Spain
facility: Hospital de Jerez
state: Andalucía/Cádiz
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
state: Andalucía/Granada
city: Málaga
country: Spain
facility: Hospital Carlos Haya
state: Andalucía/Málaga
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
state: Andalucía/Sevilla
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
state: Andalucía/Sevilla
city: Córdoba
country: Spain
facility: Hospital Univ. Reina Sofia
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
state: Aragón
city: Gijón
country: Spain
facility: Hospital Universitario Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Baleares
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla-León
city: León
country: Spain
facility: Hospital de León
state: Castilla-León
city: Salamanca
country: Spain
facility: Complejo Hospitalario de Salamanca
state: Castilla-León
city: Valladolid
country: Spain
facility: Clínico de Valladolid
state: Castilla-León
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova Lleida
state: Cataluña
city: Manresa, Barcelona
country: Spain
facility: Hospital de Althaia (H. Sant Juan de Deu de Manresa)
state: Cataluña
city: Madrid
country: Spain
facility: Hospital Infanta leonor
state: Comunidad Madrid
city: Alicante
country: Spain
facility: Hospital General Alicante
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
state: Extremadura
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
state: Galicia
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Orense
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
state: Islas Canarias
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora de Candelaria
state: Islas Canarias
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Canarias
state: Islas Canarias
city: Cartagena, Murcia
country: Spain
facility: Hospital Santa Lucía
state: Murcia
city: Pamplona, Navarra
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Bilbao, Vizcaya
country: Spain
facility: Hospital de Basurto
state: País Vasco
city: San Sebastián, Guipúzcoa
country: Spain
facility: Hospital Universitario de Donostia
state: País Vasco
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital de Getafe
Study officials:
affiliation: Celgene
name: Montserrat Rafel, RML Advocacy
role: STUDY_DIRECTOR
References: