Clinical trial NCT06891144: Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
Official title: Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AML, Adult
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive induction therapy, as defined by the group's recommendations

Brief summary: 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.


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)

Primary outcomes:
measure: describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older
timeFrame: at diagnosis (from first results related to AML until AML diagnosis) 3 months
measure: describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older
timeFrame: at diagnosis (from first results related to AML until AML diagnosis) 3 months
measure: Describe first line AML treatment received
timeFrame: 12 months
measure: characterize the Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers CHU
city: Annecy
country: France
facility: Annecy CH
city: Avignon
country: France
facility: Avignon CH
city: Bayonne
country: France
facility: Bayonne CH
city: Besançon
country: France
facility: Besançon CHU
city: Brest
country: France
facility: Brest CHU
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Colmar
country: France
facility: Colmar CH
city: Grenoble
country: France
facility: Grenoble CHU
city: Marseille
country: France
facility: Marseille IPC
city: Metz
country: France
facility: METZ-THIONVILLE CHR- Hôpital de Mercy
city: Montpellier
country: France
facility: Montpellier - Chu Saint Eloi
city: Mulhouse
country: France
facility: Mulhouse Chu
city: Nantes
country: France
facility: Nantes CHU
city: Nîmes
country: France
facility: Nimes CHU
city: Orléans
country: France
facility: Orléans CHU
city: Paris
country: France
facility: Paris Cochin, APHP
city: Perpignan
country: France
facility: Perpignan CH
city: Pessac
country: France
facility: Bordeaux CHU
city: Poitiers
country: France
facility: Poitiers CHU
city: Reims
country: France
facility: Reims CHU
city: Rennes
country: France
facility: Rennes CHU
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: ICANS - Institut de cancérologie de strasbourg europe
city: Toulouse
country: France
facility: Toulouse - IUCT Oncopole - Service d'Hématologie
city: Tours
country: France
facility: Tours CHU
city: vandoeuvre les Nancy
country: France
facility: Nancy CHU
Study officials:
affiliation: French Innovative Leukemia Organization
name: Arnaud Pigneux, Prof
role: STUDY_CHAIR
References: