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

NCT ID: NCT06891144

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-06

Study Completion Date

2031-01-06

Brief Summary

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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

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Conditions

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AML, Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Pigneux, Prof

Role: STUDY_CHAIR

French Innovative Leukemia Organization

Locations

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Angers CHU

Angers, , France

Site Status RECRUITING

Annecy CH

Annecy, , France

Site Status RECRUITING

Avignon CH

Avignon, , France

Site Status RECRUITING

Bayonne CH

Bayonne, , France

Site Status RECRUITING

Besançon CHU

Besançon, , France

Site Status RECRUITING

Brest CHU

Brest, , France

Site Status RECRUITING

CHU Estaing

Clermont-Ferrand, , France

Site Status RECRUITING

Colmar CH

Colmar, , France

Site Status RECRUITING

Grenoble CHU

Grenoble, , France

Site Status RECRUITING

Marseille IPC

Marseille, , France

Site Status RECRUITING

METZ-THIONVILLE CHR- Hôpital de Mercy

Metz, , France

Site Status RECRUITING

Montpellier - Chu Saint Eloi

Montpellier, , France

Site Status RECRUITING

Mulhouse Chu

Mulhouse, , France

Site Status RECRUITING

Nantes CHU

Nantes, , France

Site Status RECRUITING

Nimes CHU

Nîmes, , France

Site Status RECRUITING

Orléans CHU

Orléans, , France

Site Status RECRUITING

Paris Cochin, APHP

Paris, , France

Site Status RECRUITING

Perpignan CH

Perpignan, , France

Site Status RECRUITING

Bordeaux CHU

Pessac, , France

Site Status RECRUITING

Poitiers CHU

Poitiers, , France

Site Status RECRUITING

Reims CHU

Reims, , France

Site Status RECRUITING

Rennes CHU

Rennes, , France

Site Status RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

ICANS - Institut de cancérologie de strasbourg europe

Strasbourg, , France

Site Status RECRUITING

Toulouse - IUCT Oncopole - Service d'Hématologie

Toulouse, , France

Site Status RECRUITING

Tours CHU

Tours, , France

Site Status RECRUITING

Nancy CHU

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ariane Mineur

Role: CONTACT

+33 (5)57 62 31 08

Facility Contacts

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Mathilde Hunault, Prof

Role: primary

Adrien CONTEJEAN, Dr

Role: primary

Safia Chebrek, dr

Role: primary

Anne Banos, Dr

Role: primary

Yohann Desbrosses, Dr

Role: primary

Gaelle Guillerm, Dr

Role: primary

romain Guièze, Prof

Role: primary

Bruno Audhuy, Dr

Role: primary

Martin Carré, Dr

Role: primary

norbert VEY, Dr

Role: primary

Veronique DORVAUX, Dr

Role: primary

Laure Vincent, Dr

Role: primary

Mario OJEDA-URIBE, Dr

Role: primary

Pierre Peterlin, Dr

Role: primary

Stephane WICKENHAUSER, Dr

Role: primary

Magda ALEXIS, Dr

Role: primary

Role: backup

BOUSCARY Didier, Prof

Role: primary

Laurence SANHES, Dr

Role: primary

Arnaud Pigneux, MD, PhD

Role: primary

Maria-Pilar GALLEGO-HERNANZ, Dr

Role: primary

Chantal Himberlin, Dr

Role: primary

tony Marchand, Dr

Role: primary

Emmanuelle tavernier, Dr

Role: primary

Celestine SIMAND, Dr

Role: primary

Christian RECHER, Prof

Role: primary

Alban Villate, Dr

Role: primary

Caroline Bonmati, Dr

Role: primary

Other Identifiers

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FILObs_LAMSA 2013

Identifier Type: -

Identifier Source: org_study_id

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