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

NCT06512610 | Not Yet Recruiting

• 1 other identifier: 24Hemato02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Leukemia, Myeloid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Relapse free survival before alloHSCT

  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

  At the diagnosis

• Complete remission rates

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

• Safety and tolerance

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

Study Arms (1)

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

Interventions

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

Also known as: No treatment intervention. Evaluation of the European leukemia net 2022 classification.

Middle Eastern or North Coast of Africa patients with newly AML

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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"

You may not qualify if:

• 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"

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 0600, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (1)