Clinical trial · Observational
Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with AML
- description
- The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.
Primary outcomes (1)
- measure
- The median survival time in adult patients over 60 with AML diagnosis
- timeFrame
- Up to approximately 12 months
- description
- 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.
Secondary outcomes (8)
- measure
- Overall Survival
- timeFrame
- Up to approximately 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available