Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AML, Adult. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. The main aim of the study is to determine the epidemiological characteristics of AML patients, both clinically and biologically, and to correlate these to their outcome. The incidence of AML increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. The principle of treatment as in younger patients, is based on trying to achieve complete remission (CR). remission (CR). Observed complete remission rates range from 38 to 70%. Long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years. years. However, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. As shown by Swedish registry studies, it is associated with improved life expectancy. The proportion of patients who can receive intensive initial treatment is not well known in France, probably varies widely from one region to another, and certainly decreases with increasing age. Only the registry studies currently underway will enable us to assess this precisely.
Primary outcome measures
- describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older [Time frame: at diagnosis (from first results related to AML until AML diagnosis) 3 months]
- describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older [Time frame: at diagnosis (from first results related to AML until AML diagnosis) 3 months]
- Describe first line AML treatment received [Time frame: 12 months]
- characterize the Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients aged 60 and over
- Patients with previously untreated de novo or secondary AML
- Patients suitable for standard intensive treatment
- Patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent).
Exclusion criteria
- Patients with AML 3
- Patients with severe, uncontrolled infection at the time of inclusion
- Patients with psychiatric or social disorders that will prevent compliance with the protocol
- Patients without health insurance (affiliation to a social security scheme)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 27 centers
- Angers CHU — Angers
- Annecy CH — Annecy
- Avignon CH — Avignon
- Bayonne CH — Bayonne
- Besançon CHU — Besançon
- Brest CHU — Brest
- CHU Estaing — Clermont-Ferrand
- Colmar CH — Colmar
- … and 19 more centers
Identifiers
NCT: NCT06891144 · FILObs_LAMSA 2013