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
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,
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- 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.
- 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