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

Not yet recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT05558943
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Study Start: 2025-10
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

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

Exclusion Criteria

• Minor patients
• Acute promyelocytic leukemia (AML3)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years after diagnosis

Secondary Outcome Measures

Name	Time	Method
Side effects	24 months	according to the CTCAE v5.0 classification
Leukemia free survival rate	24 months
Incomplete cytological remission rate	after the phase of induction up to 24 months
Cytological remission rate	after the phase of induction up to 24 months
the rate of patients receiving intensive treatment	24 months
Overall survival	1 year after diagnosis

Trial Locations

Locations (1)

Department of Hematology, Hospital Saint Antoine; 🇫🇷 Paris, France