Acute Myeloblastic LeukemiaLAMMENCT07250217
Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
A study testing Epigenetic markers in people with Acute Myeloblastic Leukemia, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.
Trial summary
The main objective of this study is to identify epigenetic markers specific to abnormal myeloid cells in patients with acute myeloid leukemia (AML) by analyzing the methylation of circulating cell-free DNA in plasma. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloblastic Leukemia
- What is being tested?
- Epigenetic markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Jan 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years;
- Scheduled for cardiac surgery involving sternotomy;
- Normal blood count within the two months preceding sampling;
- Affiliated with, or beneficiary of, a social security system;
- Written informed consent to participate in the study.
- Age ≥ 60 years;
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- Diagnosis of de novo AML or AML secondary to myelodysplastic syndrome, scheduled to receive azacitidine-based treatment;
- Affiliated with, or beneficiary of, a social security system;
- Written informed consent to participate in the study.
Who cannot join
- Patients deemed unsuitable for sampling by the surgeon performing the procedure;
- Patients under legal protection measures;
- Patients under judicial supervision or deprived of liberty by judicial or administrative decision;
- Presence of positive virological markers indicating active infection (hepatitis B, hepatitis C, or HIV).
- / AML Group
- Diagnosis of a hematologic disease other than AML;
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- Clinical signs suggestive of active central nervous system leukemia, or presence of isolated extramedullary leukemia;
- Previous treatment for AML other than hydroxyurea;
- Severe comorbidities that could interfere with the study, as assessed by the principal investigator;
- Presence of positive virological markers indicating active infection (hepatitis B, hepatitis C, or HIV);
- Patients under legal protection;
- Patients under judicial supervision or deprived of liberty by judicial or administrative decision.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse, Alsace, 68100
Bernard Drénou, MD, +33389647755, drenoub@ghrmsa.fr
Gheorghe Gavra, MD
- Recruiting
GHRMSA
Mulhouse, 68100
Bernard DRENOU, MD, +33389646464, drenoub@ghrmsa.fr
Gheorghe Gavra, MD
About this study
Official title: Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
The main objective of this study is to identify epigenetic markers specific to abnormal myeloid cells in patients with acute myeloid leukemia (AML) by analyzing the methylation of circulating cell-free DNA in plasma.
Read the detailed description
Secondary objectives:
- To evaluate the correlation between epigenetic markers and clinical response to treatment with Azacytidine.
- To compare methylation patterns between patients who respond and those who do not respond to treatment of AML.
Conduct of research:
This study will allow the collection of samples for the establishment of a biobank. The study population is divided into two groups:
Control group: Elderly patients scheduled for thoracic surgery involving sternotomy. A bone marrow sample (2 mL) will be obtained by sternal puncture in the operating room (after general anesthesia and before sternotomy), and an additional blood sample (10 mL) will be collected during the hospital stay.
AML group: Elderly patients diagnosed with acute myeloid leukemia. An additional volume of blood (10 mL) and bone marrow (2 mL) will be collected during follow-up visits as part of their routine care.
- Conditions
- Acute Myeloblastic Leukemia
- Being tested
- Epigenetic markers
- Keywords
- Acute Myeloblastic Leukemia, Methylome, Epigenetic markers, Bone marrow, Diagnosis
- Medical subject headings
- Leukemia, Myeloid, Acute, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigenetic markersDiagnostic test
Methylation profiles will be analyzed and DNA regions (CpG sites) that show significant differences between healthy and pathological cells from bone marrow will be identified. These regions could serve as epigenetic markers for cells from patients with LAM, if they can be used by digital PCR. These differentially methylated CpG islands will be targeted for the design of specific primer and probe pairs for use in digital PCR. The markers will then be tested in circulating free DNA from blood.
| Study group | Role | What they receive |
|---|---|---|
| AML | Other | Elderly patients diagnosed with acute myeloid leukemia. An additional volume of blood (10 mL) and bone marrow (2 mL) will be collected during follow-up visits as part of their routine care. Receives: Diagnostic Test: Epigenetic markers |
| Control group | Other | Elderly patients scheduled for thoracic surgery involving sternotomy. A bone marrow sample (2 mL) will be obtained by sternal puncture in the operating room (after general anesthesia and before sternotomy), and an additional blood sample (10 mL) will be collected during the hospital stay. Receives: Diagnostic Test: Epigenetic markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of methylation of specific CpG sites
The methylation of circulating free DNA in plasma is quantified by measuring the percentage of methylation of specific CpG motifs analyzed in cfDNA relative to total methylation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start13 Jan 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloblastic LeukemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Hématologie et Transplantation (IRHT)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250217
- Sponsor's protocol ID
- GHRMSA 1447
- Acronym
- LAMME
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Biological Samples for Research Purposes: Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients
- ClinicalTrials.gov ID
- NCT07250217
- Acronym / sponsor ID
- LAMME / GHRMSA 1447
- Conditions
- Acute Myeloblastic Leukemia
- Keywords
- Acute Myeloblastic Leukemia, Methylome, Epigenetic markers, Bone marrow, Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Collaborators
- Institut de Recherche en Hématologie et Transplantation (IRHT)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Nov 2025 (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.
The main objective of this study is to identify epigenetic markers specific to abnormal myeloid cells in patients with acute myeloid leukemia (AML) by analyzing the methylation of circulating cell-free DNA in plasma.
Detailed description
Secondary objectives:
- To evaluate the correlation between epigenetic markers and clinical response to treatment with Azacytidine.
- To compare methylation patterns between patients who respond and those who do not respond to treatment of AML.
Conduct of research:
This study will allow the collection of samples for the establishment of a biobank. The study population is divided into two groups:
Control group: Elderly patients scheduled for thoracic surgery involving sternotomy. A bone marrow sample (2 mL) will be obtained by sternal puncture in the operating room (after general anesthesia and before sternotomy), and an additional blood sample (10 mL) will be collected during the hospital stay.
AML group: Elderly patients diagnosed with acute myeloid leukemia. An additional volume of blood (10 mL) and bone marrow (2 mL) will be collected during follow-up visits as part of their routine care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AML | Other | Diagnostic Test: Epigenetic markersElderly patients diagnosed with acute myeloid leukemia. An additional volume of blood (10 mL) and bone marrow (2 mL) will be collected during follow-up visits as part of their routine care. |
| Control group | Other | Diagnostic Test: Epigenetic markersElderly patients scheduled for thoracic surgery involving sternotomy. A bone marrow sample (2 mL) will be obtained by sternal puncture in the operating room (after general anesthesia and before sternotomy), and an additional blood sample (10 mL) will be collected during the hospital stay. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 60 years;
- Diagnosis of de novo AML or AML secondary to myelodysplastic syndrome, scheduled to receive azacitidine-based treatment;
- Affiliated with, or beneficiary of, a social security system;
- Written informed consent to participate in the study.
Key exclusion criteria (12 listed)
- / AML Group
- Diagnosis of a hematologic disease other than AML;
- Clinical signs suggestive of active central nervous system leukemia, or presence of isolated extramedullary leukemia;
- Previous treatment for AML other than hydroxyurea;
- Severe comorbidities that could interfere with the study, as assessed by the principal investigator;
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 |
|---|---|---|
| Epigenetic markersMethylation profiles will be analyzed and DNA regions (CpG sites) that show significant differences between healthy and pathological cells from bone marrow will be identified. These regions could serve as epigenetic markers for cells from patients with LAM, if they can be used by digital PCR. These differentially methylated CpG islands will be targeted for the design of specific primer and probe pairs for use in digital PCR. The markers will then be tested in circulating free DNA from blood. | Diagnostic test | AML, Control group |
Primary outcome
Percentage of methylation of specific CpG sites
Time frame: Baseline
The methylation of circulating free DNA in plasma is quantified by measuring the percentage of methylation of specific CpG motifs analyzed in cfDNA relative to total methylation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigenetic markers in people with Acute Myeloblastic Leukemia, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard DRENOU, Dr (+33389646464, drenoub@ghrmsa.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of methylation of specific CpG sites (time frame: Baseline). 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 4 Feb 2026.