AML, AdultNCT06891144
Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy
An observational study of AML, Adult, run by French Innovative Leukemia Organisation at 27 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- AML, Adult
- How many people
- 1,000 participants
- Where
- 27 sitesFrance
- Study dates
- 6 Jan 2015to 6 Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
France27 sites, 27 recruiting
- Recruiting
Angers CHU
Angers
Mathilde Hunault, Prof, mahunault@chu-angers.fr
- Recruiting
Annecy CH
Annecy
Adrien CONTEJEAN, Dr, acontejean@ch-annecygenevois.fr
- Recruiting
Avignon CH
Avignon
Safia Chebrek, dr, chebrek.safia@ch-avignon.fr
- Recruiting
Bayonne CH
Bayonne
Anne Banos, Dr, abanos@ch-cotebasque.fr
- Recruiting
Besançon CHU
Besançon
Yohann Desbrosses, Dr, ydesbrosses@chu-besancon.fr
- Recruiting
Brest CHU
Brest
Gaelle Guillerm, Dr, gaelle.guillerm@chu-brest.fr
- Recruiting
CHU Estaing
Clermont-Ferrand
romain Guièze, Prof, rguieze@chu-clermontferrand.fr
- Recruiting
Colmar CH
Colmar
Bruno Audhuy, Dr, bruno.audhuy@ch-colmar.fr
- Recruiting
Grenoble CHU
Grenoble
Martin Carré, Dr, MCarre1@chu-grenoble.fr
- Recruiting
Marseille IPC
Marseille
norbert VEY, Dr, VEYN@ipc.unicancer.fr
- Recruiting
METZ-THIONVILLE CHR- Hôpital de Mercy
Metz
Veronique DORVAUX, Dr, v.dorvaux@chr-metz-thionville.fr
- Recruiting
Montpellier - Chu Saint Eloi
Montpellier
Laure Vincent, Dr, l-vincent@chu-montpellier.fr
- Recruiting
Mulhouse Chu
Mulhouse, 68100
Mario OJEDA-URIBE, Dr, ojeda-uribem@ghrmsa.fr
Mario ODJEDA-URIBE
- Recruiting
Nantes CHU
Nantes
Pierre Peterlin, Dr, pierre.peterlin@chu-nantes.fr
- Recruiting
Nimes CHU
Nîmes
Stephane WICKENHAUSER, Dr, stefan.wickenhauser@chu-nimes.fr
- Recruiting
Orléans CHU
Orléans, 45000
Magda ALEXIS, Dr
magda.alexis@chr-orleans.fr
- Recruiting
Paris Cochin, APHP
Paris
BOUSCARY Didier, Prof, didier.bouscary@cch.aphp.fr
- Recruiting
Perpignan CH
Perpignan
Laurence SANHES, Dr, laurence.sanhes@ch-perpignan.fr
- Recruiting
Bordeaux CHU
Pessac
Arnaud Pigneux, MD, PhD, arnaud.pigneux@chu-bordeaux.fr
- Recruiting
Poitiers CHU
Poitiers
Maria-Pilar GALLEGO-HERNANZ, Dr, Maria-Pilar.GALLEGO-HERNANZ@chu-poitiers.fr
- Recruiting
Reims CHU
Reims
Chantal Himberlin, Dr, chimberlin@chu-reims.fr
- Recruiting
Rennes CHU
Rennes
tony Marchand, Dr, tony.marchand@chu-rennes.fr
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez
Emmanuelle tavernier, Dr, emmanuelle.tavernier@chu-st-etienne.fr
- Recruiting
ICANS - Institut de cancérologie de strasbourg europe
Strasbourg
Celestine SIMAND, Dr, c.simand@icans.eu
- Recruiting
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse
Christian RECHER, Prof, recher.christian@iuct-oncopole.fr
- Recruiting
Tours CHU
Tours
Alban Villate, Dr, a.villate@chu-tours.fr
- Recruiting
Nancy CHU
Vandœuvre-lès-Nancy
Caroline Bonmati, Dr, c.bonmati@chu-nancy.fr
About this study
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.
- Conditions
- AML, Adult
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: at diagnosis (from first results related to AML until AML diagnosis) 3 months
Describe first line AML treatment received
type of treatment
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start6 Jan 2015
- Primary completion6 Jan 2030 (estimated)
- Study completion6 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Pigneux, Prof, Study chair, French Innovative Leukemia Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891144
- Sponsor's protocol ID
- FILObs_LAMSA 2013
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06891144
- Acronym / sponsor ID
- FILObs_LAMSA 2013
- Conditions
- AML, Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 6 Jan 2030 (estimated)
- Study completion
- 6 Jan 2031 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud Pigneux, Prof study chair
French Innovative Leukemia Organization
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, Adult, run by French Innovative Leukemia Organisation at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariane Mineur (+33 (5)57 62 31 08, ariane.mineur@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.