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

Celgene

Status: Completed

Conditions: Leukemia, Myeloid, Acute

Study type: Observational

Funder types: Industry

Identifiers

NCT03435341

NDS-AML-001

U1111-1207-6661 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

151 participants in 1 patient group

Patients diagnosed with AML

Description:

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