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

March 20, 2025 updated by: French Innovative Leukemia Organisation

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: at diagnosis (from first results related to AML until AML diagnosis) 3 months
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
Time Frame: 12 months
type of treatment
12 months
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Study Chair: Arnaud Pigneux, Prof, French Innovative Leukemia Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2015

Primary Completion (Estimated)

January 6, 2030

Study Completion (Estimated)

January 6, 2031

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FILObs_LAMSA 2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AML, Adult

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe