Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy

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.

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Key information

Conditions

AML, Adult Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers CHU, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

Values for leukocytosis, blasts, neutrophils, and platelets (in /mm3)
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

the cytogenetic pronosis according ELN criteria
Describe first line AML treatment received

Time frame: 12 months

type of treatment
characterize the Overall survival (OS)

Time frame: 5 years

defined as the time from date of initiation of chemotherapy to date of death due to any cause. Patients still alive or lost to follow up will be censored at the time they were last known to be alive

Study contacts

Contact information is provided by the study sponsor or research team.

Ariane Mineur

CONTACT

[email protected]

+33 (5)57 62 31 08

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2030
Study completion: 2031
First posted: Mar 24, 2025
Registry last updated: Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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