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

ConditionAML, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorFrench Innovative Leukemia Organisation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
at diagnosis (from first results related to AML until AML diagnosis) 3 months
2

describe the initial characteristics of Acute myeloid leukemia (AML) in patients aged 60 years and older

the cytogenetic pronosis according ELN criteria

Time frame
at diagnosis (from first results related to AML until AML diagnosis) 3 months
3

Describe first line AML treatment received

type of treatment

Time frame
12 months
4

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

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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