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

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

NCT ID: NCT05558943

Condition: Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute

Conditions: Keywords:
Prognosis of Acute myeloblastic leukemia

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Other

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

Criteria for eligibility:

Study pop:
Adult patients treated for AML at Saint-Antoine hospital

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Age :18 years and older - Patients with AML - Non objection to research Exclusion Criteria: - Minor patients - Acute promyelocytic leukemia (AML3)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Hematology, Hospital Saint Antoine

Address:
City: Paris
Zip: 75012
Country: France

Start date: October 2022

Completion date: June 2026

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05558943