Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
"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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Middle Eastern or North Coast of Africa patients with newly AML | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Middle Eastern or North Coast of Africa patients with newly AML
- description
- Validation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients
- interventionNames
- Other: Middle Eastern or North Coast of Africa patients with newly AML
Primary outcomes (1)
- measure
- Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017
- timeFrame
- Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
- description
- Patient alive or not. Patient alive at last follow-up were censored.
Secondary outcomes (4)
- measure
- Relapse free survival before alloHSCT
- timeFrame
- Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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"
References
Publications (0)
Data not yet available