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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

"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."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

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"

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Middle Eastern or North Coast of Africa patients with newly AML

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Middle Eastern or North Coast of Africa patients with newly AML1 intervention

Trial outcomes

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

Secondary outcomes

1

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 frame
Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025
2

Risk group according to 2017 and 2022 ELN

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

Time frame
At the diagnosis
3

Complete remission rates

complete remission rates %

Time frame
Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
4

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

Other outcomes

Sponsors and contacts

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