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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05558943
Collaborator
(none)
750
Enrollment
1
Location
44
Anticipated Duration (Months)
17
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    750 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2026
    Anticipated Study Completion Date :
    Jun 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [2 years after diagnosis]

    Secondary Outcome Measures

    1. Overall survival [6 months after diagnosis]

    2. Overall survival [1 year after diagnosis]

    3. Cytological remission rate [after the phase of induction up to 24 months]

    4. Incomplete cytological remission rate [after the phase of induction up to 24 months]

    5. Leukemia free survival rate [24 months]

    6. Side effects [24 months]

      according to the CTCAE v5.0 classification

    7. the rate of patients receiving intensive treatment [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age :18 years and older

    • Patients with AML

    • Non objection to research

    Exclusion Criteria:

    • Minor patients

    • Acute promyelocytic leukemia (AML3)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hematology, Hospital Saint Antoine Paris France 75012

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Alexis GENTHON, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05558943
    Other Study ID Numbers:
    • APHP211337
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 28, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Prognosis of Acute myeloblastic leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Sep 28, 2022