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NCT Number: NCT05558943

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Hematology, Hospital Saint Antoine

Paris, 75012, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor patients
  • Acute promyelocytic leukemia (AML3)

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years after diagnosis

Secondary outcomes

  1. Overall survival

    Time frame: 6 months after diagnosis

  2. Overall survival

    Time frame: 1 year after diagnosis

  3. Cytological remission rate

    Time frame: after the phase of induction up to 24 months

  4. Incomplete cytological remission rate

    Time frame: after the phase of induction up to 24 months

  5. Leukemia free survival rate

    Time frame: 24 months

  6. Side effects

    Time frame: 24 months

    according to the CTCAE v5.0 classification

  7. the rate of patients receiving intensive treatment

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alexis GENTHON, MD

CONTACT

[email protected]

01 49 28 53 44

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: LAMSA

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 28, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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