Clinical trial NCT05558943: Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
Official title: Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Prognosis of Acute myeloblastic leukemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated for AML at Saint-Antoine hospital

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Minor patients
* Acute promyelocytic leukemia (AML3)

Primary outcomes:
measure: Overall survival
timeFrame: 2 years after diagnosis
Secondary outcomes:
measure: Overall survival
timeFrame: 6 months after diagnosis
measure: Overall survival
timeFrame: 1 year after diagnosis
measure: Cytological remission rate
timeFrame: after the phase of induction up to 24 months
measure: Incomplete cytological remission rate
timeFrame: after the phase of induction up to 24 months
measure: Leukemia free survival rate
timeFrame: 24 months
measure: Side effects
timeFrame: 24 months
measure: the rate of patients receiving intensive treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Hematology, Hospital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexis GENTHON, MD
role: PRINCIPAL_INVESTIGATOR
References: