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NCT Number: NCT06512610

ELN 2022 in MENAFC ( Middle Eastern or North Coast of Africa ) Patients With Newly AML

"In daily clinical practice, 2022 ELN guidelines were used to predict response to conventional treatment and to guide the need for allogenic stem cell transplantation. But, the team has to underline that ELN guidelines are mainly reflective of relatively young Caucasian patients. Few studies have compared 2017 and 2022 ELN in ethnicity cohorts to evaluate the potential prognostic value of this new criteria in these types of population. For example, with the 2022 ELN guidelines, the disease-free surviva) and the overall survival of African American < 60 y.o were not statistically different between intermediate and adverse groups (p=0.30, p=0,46). There were not a significant difference between favorable and intermediate groups in DFS (p=0.42, p=0.42) respectively in African American and Hispanic patients or in OS (p=0.67) in Hispanic patients. Is the 2022 ELN applicable to all ethnic subgroups? To date, no studies have examined and validated its applicability in Middle Eastern or North Coast of Africa (MENAFC) patients."

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Key information

Conditions

Leukemia, Myeloid Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed AML
  • At least 18 yo
  • MENAFC (Middle East ern of North Coast of Africa) patients with HLA HLA > 50%
  • ECOG performance status of 0,1,2,3"

Exclusion criteria

  • Acute promyelocytic leukemia
  • Patients alive at the start of the study who did not receive study information or who objected to the collection of data"

Treatment and study plan

Middle Eastern or North Coast of Africa patients with newly AML

Other

Validation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients

Other names: No treatment intervention. Evaluation of the European leukemia net 2022 classification.

Primary outcomes

  1. Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017

    Time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025

    Patient alive or not. Patient alive at last follow-up were censored.

Secondary outcomes

  1. Relapse free survival before alloHSCT

    Time frame: Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025

    Patient who relapsed (confirmation with bone marow sample or MRD + Minimum residual Disease) / who died from any cause during the follow-up or patient with complete remission.

  2. Risk group according to 2017 and 2022 ELN

    Time frame: At the diagnosis

    Presence of genetic abnormalities resulting in 3 risks categories: favorable, Intermediate and Adverse

  3. Complete remission rates

    Time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025

    complete remission rates %

  4. Safety and tolerance

    Time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025

    "Number of chemotherapy-related adverse events. Adverse events (AEs) were evaluated according to Common Terminology Criteria for Adverse Events classification: CTCAE (Version 4.0). Grade 1 = Mild - transient or mild discomfort; no limitation in activity; no medical intervention/therapy required

    • Grade 2 = Moderate - mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required
    • Grade 3 = Severe - marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization is possible
    • Grade 4 = Life threatening - extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable
    • Grade 5 = Death "

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Validation of the Use of the "ELN 2022" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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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