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Not yet recruiting NCT05558943

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

Observational Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Overall survival [Time frame: 2 years after diagnosis]
Secondary outcome measures (7)
  • Overall survival [Time frame: 6 months after diagnosis]
  • Overall survival [Time frame: 1 year after diagnosis]
  • Cytological remission rate [Time frame: after the phase of induction up to 24 months]
  • Incomplete cytological remission rate [Time frame: after the phase of induction up to 24 months]
  • Leukemia free survival rate [Time frame: 24 months]
  • Side effects [Time frame: 24 months]
  • the rate of patients receiving intensive treatment [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Minor patients
  • Acute promyelocytic leukemia (AML3)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Department of Hematology, Hospital Saint Antoine — Paris

Identifiers

NCT: NCT05558943 · APHP211337

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗