Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
1 other identifier
observational
1,000
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2015
CompletedFirst Submitted
Initial submission to the registry
March 14, 2025
CompletedFirst Posted
Study publicly available on registry
March 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 6, 2031
March 24, 2025
March 1, 2025
15 years
March 14, 2025
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older
Values for leukocytosis, blasts, neutrophils, and platelets (in /mm3)
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
the cytogenetic pronosis according ELN criteria
at diagnosis (from first results related to AML until AML diagnosis) 3 months
Describe first line AML treatment received
type of treatment
12 months
characterize the Overall survival (OS)
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
5 years
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- Patients with AML 3
- Patients with psychiatric or social disorders that will prevent compliance with the protocol
- Patients without health insurance (affiliation to a social security scheme)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
METZ-THIONVILLE CHR- Hôpital de Mercy
Metz, France
Montpellier - Chu Saint Eloi
Montpellier, France
Mulhouse Chu
Mulhouse, 68100, France
Nantes CHU
Nantes, France
Nimes CHU
Nîmes, France
Orléans CHU
Orléans, 45000, France
Paris Cochin, APHP
Paris, France
Perpignan CH
Perpignan, France
Bordeaux CHU
Pessac, France
Poitiers CHU
Poitiers, France
Reims CHU
Reims, France
Rennes CHU
Rennes, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
ICANS - Institut de cancérologie de strasbourg europe
Strasbourg, France
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse, France
Tours CHU
Tours, France
Nancy CHU
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Arnaud Pigneux, Prof
French Innovative Leukemia Organization
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2025
First Posted
March 24, 2025
Study Start
January 6, 2015
Primary Completion (Estimated)
January 6, 2030
Study Completion (Estimated)
January 6, 2031
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share