Leukemia, Myeloid
Conditions
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.
Interventions
OTHERMiddle 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
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | At the diagnosis | Presence of genetic abnormalities resulting in 3 risks categories: favorable, Intermediate and Adverse |
| Complete remission rates | Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025 | complete remission rates % |
| Safety and tolerance | 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 |
Countries
France
Outcome results
None listed