Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital

NCT ID: NCT05558943

Last Updated: 2025-04-02

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

NOT_YET_RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2030-06-30

Brief Summary

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AML in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. In order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. The objective of this study is:

* To describe the AML treated within the hematology department
* To optimize the management of patients with AML.

Detailed Description

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Current state of knowledge:

Acute myeloblastic leukemia are the most common leukemias in adults. This pathology is very heterogeneous. It has a poor prognosis despite numerous therapeutic advances. The lack of randomized clinical trials can make certain treatment decisions difficult. In addition, patients with comorbidities or the elderly are most often excluded from these trials even though they represent a significant proportion of new diagnoses.

Objectives:

Primary objective Evaluate the overall survival of adult patients treated for AML in our hematology department at Saint-Antoine Hospital.

Secondary objectives

* Evaluate early mortality at 30 days and 60 days post-induction
* Evaluate the CR/CRi rate after induction
* Evaluate the toxicity of the treatments
* Evaluate the relapse-free survival time
* Assess the prognostic value of JC-1 at diagnosis
* Evaluate the proportion of patients eligible for intensive treatment and/or allograft
* Evaluate the side effects of the treatments undertaken
* Describe the molecular and cytogenetic characteristics of hemopathies at diagnosis and at relapse

Duration of study:

Retrospective cohort (cohort A): patients diagnosed between junuary1,2010 and May 30,2022 Prospective cohort (cohort B): patients diagnosed between June 1, 2022 and December 31, 2023. A follow-up of 2 years will be necessary after the end of treatment.

The end of follow-up is estimated at December 2025 for the entire cohort.

Data collection:

Collection of clinical and biological data in the patient's medical file via the Orbis software

Population:

Adult patients treated for AML at Saint-Antoine hospital

Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Age :18 years and older
* Patients with AML
* Non objection to research

Exclusion Criteria

* Minor patients
* Acute promyelocytic leukemia (AML3)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis GENTHON, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Department of Hematology, Hospital Saint Antoine

Paris, , France

Site Status

Countries

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France

Central Contacts

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Alexis GENTHON, MD

Role: CONTACT

01 49 28 53 44

Other Identifiers

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APHP211337

Identifier Type: -

Identifier Source: org_study_id

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