ELN 2022 in MENAFC ( Middle Eastern or North Coast of Africa ) Patients With Newly AML
NCT Number: NCT06512610
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Leukemia, Myeloid
Interventions: OTHER: Middle Eastern or North Coast of Africa patients with newly AML
Sponsor: Centre Hospitalier Universitaire de Nice
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2025-01-01
Locations: CHU NICE, Nice, Alpes Maritimes, 0600, France

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."

Primary Outcome Measures: 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 Outcome Measures: 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 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, Presence of genetic abnormalities resulting in 3 risks categories: favorable, Intermediate and Adverse, At the diagnosis|Complete remission rates, complete remission rates %, Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025|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 from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025