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

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

"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."

Study Overview

• Status: Not yet recruiting
• Conditions: Leukemia, Myeloid
• Intervention / Treatment: Other: Middle Eastern or North Coast of Africa patients with newly AML

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 0600
      • CHU Nice
      • Contact: Thomas CLUZEA; Phone Number: +33 0492039025; Email: cluzeau.t@chu-nice.fr
      • Contact: CAROLINE FILENI; Email: fileni.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

HLA, Middle Eastern or North Coast of Africa, acute myeloid leukemia patients

Description

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"

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Middle Eastern or North Coast of Africa patients with newly AML; Validation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients	Other: Middle Eastern or North Coast of Africa patients with newly AML; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017	Patient alive or not. Patient alive at last follow-up were censored.	Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse free survival before alloHSCT	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.	Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025
Risk group according to 2017 and 2022 ELN	Presence of genetic abnormalities resulting in 3 risks categories: favorable, Intermediate and Adverse	At the diagnosis
Complete remission rates	complete remission rates %	Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Safety and tolerance	"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 "	Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia; Leukemia, Myeloid
• Other Study ID Numbers: 24Hemato02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No