Leukemia, MyeloidNCT06512610
ELN 2022 in MENAFC ( Middle Eastern or North Coast of Africa ) Patients With Newly AML
An observational study of Leukemia, Myeloid, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- Middle Eastern or North Coast of Africa patients with newly AML
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HLA, Middle Eastern or North Coast of Africa, acute myeloid leukemia patients
Who may be able to join
- 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"
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
CHU NICE
Nice, Alpes Maritimes, 0600
Thomas CLUZEA, 0492039025 ext. +33, cluzeau.t@chu-nice.fr
CAROLINE FILENI, fileni.c@chu-nice.fr
About this study
Official title: Validation of the Use of the "ELN 2022" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia
"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
- Leukemia, Myeloid
- Being tested
- Middle Eastern or North Coast of Africa patients with newly AML
- Medical subject headings
- Leukemia, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Eastern or North Coast of Africa patients with newly AMLOther
Also called No treatment intervention. Evaluation of the European leukemia net 2022 classification.
Validation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients
| Study group | Role | What they receive |
|---|---|---|
| Middle 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 Receives: Other: Middle Eastern or North Coast of Africa patients with newly AML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Secondary outcomes (4)
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.
Measured: 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
Measured: At the diagnosis
Complete remission rates
complete remission rates %
Measured: 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 "
Measured: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512610
- Sponsor's protocol ID
- 24Hemato02
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Use of the "ELN 2022" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06512610
- Acronym / sponsor ID
- 24Hemato02
- Conditions
- Leukemia, Myeloid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle Eastern or North Coast of Africa patients with newly AML | – | Other: Middle Eastern or North Coast of Africa patients with newly AMLValidation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HLA, Middle Eastern or North Coast of Africa, acute myeloid leukemia patients
Key inclusion criteria (4 listed)
- 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"
Key exclusion criteria (2 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle Eastern or North Coast of Africa patients with newly AMLAlso: No treatment intervention. Evaluation of the European leukemia net 2022 classification.Validation and refinement of the 2022 European LeukemiaNet genetic risk stratification of acute myeloid leukemia in MENAFC patients | Other | Middle Eastern or North Coast of Africa patients with newly AML |
Primary outcome
Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017
Time frame: 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.
4 secondary outcomes
Relapse free survival before alloHSCT
Time frame: 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
Time frame: At the diagnosis
Complete remission rates
Time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Safety and tolerance
Time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017 (time frame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.