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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Middle Eastern or North Coast of Africa patients with newly AML
Other interventionValidation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Risk group according to 2017 and 2022 ELN
Presence of genetic abnormalities resulting in 3 risks categories: favorable, Intermediate and Adverse
Complete remission rates
complete remission rates %
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 "
Sponsors and contacts
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