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

Recruiting

• Conditions: AML, Adult

• Registration Number: NCT06891144
• Lead Sponsor: French Innovative Leukemia Organisation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-06
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2030-01-06
• Study Completion: 2031-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older	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	12 months	type of treatment
characterize the Overall survival (OS)	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

Trial Locations

Locations (27)

Angers CHU; 🇫🇷 Angers, France

Annecy CH; 🇫🇷 Annecy, France

Avignon CH; 🇫🇷 Avignon, France

Bayonne CH; 🇫🇷 Bayonne, France

Besançon CHU; 🇫🇷 Besançon, France

Brest CHU; 🇫🇷 Brest, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Colmar CH; 🇫🇷 Colmar, France

Grenoble CHU; 🇫🇷 Grenoble, France

Marseille IPC; 🇫🇷 Marseille, France

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