Leukaemia (Acute Myeloid)ENKLA-MNCT07249476
Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia
An observational study of Leukaemia (Acute Myeloid) and Leukaemia (Acute Lymphoblastic), run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the ENKLA-M study is to collect samples from patients with acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), and myelodysplastic syndrome (MDS) to study the evolution of blast phenotype (NK receptor ligands and adhesion molecules) and the biology of patients' NK cells). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukaemia (Acute Myeloid), Leukaemia (Acute Lymphoblastic), Myelodysplastic Syndrome
- What is being tested?
- Bone marrow sampling (during routine care) and Blood samples (during routine care)
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 1 Jun 2030
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with AML, ALL or MDS treated in the haematology department of Nantes University Hospital. The number of transplants performed for these conditions in the department suggests that 55 patients could be recruited at diagnosis (30 LAM patients, 10 LAL patients and 15 SMD patients). Among the LAM and SMD patients (n=45), we will identify 40 patients for post-transplant studies: >20 LAM/SMD patients receiving a matched transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group). >20 LAM/SMD patients receiving a haploidentical transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group).
Who may be able to join
- Adult patients diagnosed with acute myeloid leukaemia (LAM), acute lymphoblastic leukaemia (LAL) or myelodysplastic syndrome (SMD).
- Adult patients receiving a HSC transplant.
- Adult patients receiving or not AZA treatment after transplantation.
- Patients who have signed a consent form.
- Patients affiliated with a social security system. EXCLUSION CRITERIA
- Minors,
Show all 9Show fewer
- Pregnant and/or breastfeeding women
- Adult patients under guardianship,
- Protected persons.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Nantes
Nantes, 44093
Patrice CHEVALLIER, 0240083994, patrice.chevallier@chu-nantes.fr
About this study
Official title: ENKLA-M : Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia
The aim of the ENKLA-M study is to collect samples from patients with acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), and myelodysplastic syndrome (MDS) to study the evolution of blast phenotype (NK receptor ligands and adhesion molecules) and the biology of patients' NK cells). To do this, blood and bone marrow samples will be collected from patients at diagnosis in order to characterize: (I) the phenotype of ALL and AML blasts with respect to NK receptor ligands and adhesion molecules; (II) the phenotypic profile of NK cells, (III) to further characterize the NK cell repertoire dynamics over time (day 30, day 60, day 90, 6 months, and 1 year), focusing on NK cell populations identified in healthy individuals as particularly effective against leukemia, by defining their phenotypic and transcriptomic profiles; and (IV) the impact of azacitidine (AZA) and donor lymphocyte infusions (DLI) on the biology of NK cells in transplanted patients. Clinical data and KIR/HLA genetic profiles will be used to analyze all NK phenotypic and functional data, with the aim of better defining: (i) the key molecular interactions between NK cells and leukemic cells; (ii) markers of NK cell anti-leukemic efficacy during hematopoietic reconstitution; and (iii) whether AZA/DLI treatment enhances the functional potential of NK cells via KIR-HLA interaction, thereby improving their effectiveness against residual disease.
- Being tested
- Bone marrow sampling (during routine care), Blood samples (during routine care)
- Keywords
- VIDAZA, CSH graft, haematopoietic stem cell, natural killer cells, NK Cells
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow sampling (during routine care)Other
Bone marrow sample (1 ml)
Blood samples (during routine care)Other
3 tubes of 10 ml per visit
| Study group | Role | What they receive |
|---|---|---|
| AZA/DLI Group | > 20 Acute myeloid leukaemia/myelodysplastic syndrome patients receiving a matched transplant: 10 patients receiving AZA/DLI for relapse prevention. 10 patients not receiving AZA/DLI (control group).
This group is monitored at diagnosis and for 12 months after transplantation. Receives: Other: Bone marrow sampling (during routine care); Other: Blood samples (during routine care) | |
| Group without AZA/DLI | > 20 Acute myeloid leukaemia/myelodysplastic syndrome patients receiving a haploidentical transplant: 10 patients receiving AZA/DLI for relapse prevention. 10 patients not receiving AZA/DLI (control group).
This group is monitored at diagnosis and for 12 months after transplantation. Receives: Other: Bone marrow sampling (during routine care); Other: Blood samples (during routine care) | |
| LAL (Acute lymphoblastic leukaemia) | 10 Patients with a (Acute lymphoblastic leukaemia).
This group is monitored at diagnosis only. Receives: Other: Bone marrow sampling (during routine care); Other: Blood samples (during routine care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the KIR and HLA genetic markers associated with an anti-leukaemic response mediated by NK cells at different stages in the progression of Acute lymphocytic leukaemia or a myalodysplasia syndrome.
Measured: 12 months
Secondary outcomes (4)
Assess the functional potential of different NK cell populations at diagnosis of acute myeloid leukaemia, acute lymphoblastic leukaemia and myelodysplastic syndrome (at each possible relapse of the patient).
Measured: 12 months
Assess NK cell reconstitution during transplant of hematopoietic stem cells.
Measured: 12 months
Assess the impact of the hypomethylating agent AZA used to prevent relapse after allogeneic transplantation for acute myeloid leukaemia or myelodysplastic syndrome on NK cells.
Measured: 12 months
Assess the impact of Donor Lymphocyte Injection used in the prevention of post-allogeneic transplant relapse on NK cells.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukaemia (Acute Myeloid)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EFS CPDL: French Blood Establishment Centre-Pays de la Loire
- Responsible party
- Sponsor
- Investigators
- Patrice CHEVALLIER, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249476
- Sponsor's protocol ID
- RC25_0333
- Other IDs
- ANSM - IDRCB
- Acronym
- ENKLA-M
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENKLA-M : Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia
- ClinicalTrials.gov ID
- NCT07249476
- Acronym / sponsor ID
- ENKLA-M / RC25_0333
- Keywords
- VIDAZA, CSH graft, haematopoietic stem cell, natural killer cells, NK Cells
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- EFS CPDL: French Blood Establishment Centre-Pays de la Loire
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 25 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 aim of the ENKLA-M study is to collect samples from patients with acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), and myelodysplastic syndrome (MDS) to study the evolution of blast phenotype (NK receptor ligands and adhesion molecules) and the biology of patients' NK cells). To do this, blood and bone marrow samples will be collected from patients at diagnosis in order to characterize: (I) the phenotype of ALL and AML blasts with respect to NK receptor ligands and adhesion molecules; (II) the phenotypic profile of NK cells, (III) to further characterize the NK cell repertoire dynamics over time (day 30, day 60, day 90, 6 months, and 1 year), focusing on NK cell populations identified in healthy individuals as particularly effective against leukemia, by defining their phenotypic and transcriptomic profiles; and (IV) the impact of azacitidine (AZA) and donor lymphocyte infusions (DLI) on the biology of NK cells in transplanted patients. Clinical data and KIR/HLA genetic profiles will be used to analyze all NK phenotypic and functional data, with the aim of better defining: (i) the key molecular interactions between NK cells and leukemic cells; (ii) markers of NK cell anti-leukemic efficacy during hematopoietic reconstitution; and (iii) whether AZA/DLI treatment enhances the functional potential of NK cells via KIR-HLA interaction, thereby improving their effectiveness against residual disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZA/DLI Group | – | Other: Bone marrow sampling (during routine care), Other: Blood samples (during routine care)> 20 Acute myeloid leukaemia/myelodysplastic syndrome patients receiving a matched transplant: 10 patients receiving AZA/DLI for relapse prevention. 10 patients not receiving AZA/DLI (control group). This group is monitored at diagnosis and for 12 months after transplantation. |
| Group without AZA/DLI | – | Other: Bone marrow sampling (during routine care), Other: Blood samples (during routine care)> 20 Acute myeloid leukaemia/myelodysplastic syndrome patients receiving a haploidentical transplant: 10 patients receiving AZA/DLI for relapse prevention. 10 patients not receiving AZA/DLI (control group). This group is monitored at diagnosis and for 12 months after transplantation. |
| LAL (Acute lymphoblastic leukaemia) | – | Other: Bone marrow sampling (during routine care), Other: Blood samples (during routine care)10 Patients with a (Acute lymphoblastic leukaemia). This group is monitored at diagnosis only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with AML, ALL or MDS treated in the haematology department of Nantes University Hospital. The number of transplants performed for these conditions in the department suggests that 55 patients could be recruited at diagnosis (30 LAM patients, 10 LAL patients and 15 SMD patients). Among the LAM and SMD patients (n=45), we will identify 40 patients for post-transplant studies: >20 LAM/SMD patients receiving a matched transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group). >20 LAM/SMD patients receiving a haploidentical transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group).
Key inclusion criteria (9 listed)
- Adult patients diagnosed with acute myeloid leukaemia (LAM), acute lymphoblastic leukaemia (LAL) or myelodysplastic syndrome (SMD).
- Adult patients receiving a HSC transplant.
- Adult patients receiving or not AZA treatment after transplantation.
- Patients who have signed a consent form.
- Patients affiliated with a social security system. EXCLUSION CRITERIA
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bone marrow sampling (during routine care)Bone marrow sample (1 ml) | Other | AZA/DLI Group, Group without AZA/DLI, LAL (Acute lymphoblastic leukaemia) |
| Blood samples (during routine care)3 tubes of 10 ml per visit | Other | AZA/DLI Group, Group without AZA/DLI, LAL (Acute lymphoblastic leukaemia) |
Primary outcome
Define the KIR and HLA genetic markers associated with an anti-leukaemic response mediated by NK cells at different stages in the progression of Acute lymphocytic leukaemia or a myalodysplasia syndrome.
Time frame: 12 months
4 secondary outcomes
Assess the functional potential of different NK cell populations at diagnosis of acute myeloid leukaemia, acute lymphoblastic leukaemia and myelodysplastic syndrome (at each possible relapse of the patient).
Time frame: 12 months
Assess NK cell reconstitution during transplant of hematopoietic stem cells.
Time frame: 12 months
Assess the impact of the hypomethylating agent AZA used to prevent relapse after allogeneic transplantation for acute myeloid leukaemia or myelodysplastic syndrome on NK cells.
Time frame: 12 months
Assess the impact of Donor Lymphocyte Injection used in the prevention of post-allogeneic transplant relapse on NK cells.
Time frame: 12 months
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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Leukaemia (Acute Myeloid)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Patrice CHEVALLIER principal investigator
Nantes University Hospital
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 Leukaemia (Acute Myeloid) and Leukaemia (Acute Lymphoblastic), run by Nantes University Hospital 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 9 inclusion and 0 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: opening soon, as of the sponsor's last update on 24 Jun 2026. 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?
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 Sponsor department (+33253482835, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the KIR and HLA genetic markers associated with an anti-leukaemic response mediated by NK cells at different stages in the progression of Acute lymphocytic leukaemia or a myalodysplasia syndrome. (time frame: 12 months). 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 24 Jun 2026.