Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia (ENKLA-M)

April 28, 2026 updated by: Nantes University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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).

Description

INCLUSION CRITERIA

  • 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,
  • Pregnant and/or breastfeeding women
  • Adult patients under guardianship,
  • Protected persons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Bone marrow sampling (during routine care)
Bone marrow sample (1 ml)
Other: Blood samples (during routine care)
3 tubes of 10 ml per visit
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.
Other: Bone marrow sampling (during routine care)
Bone marrow sample (1 ml)
Other: Blood samples (during routine care)
3 tubes of 10 ml per visit
LAL (Acute lymphoblastic leukaemia)

10 Patients with a (Acute lymphoblastic leukaemia).

This group is monitored at diagnosis only.
Other: Bone marrow sampling (during routine care)
Bone marrow sample (1 ml)
Other: Blood samples (during routine care)
3 tubes of 10 ml per visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months
Assess NK cell reconstitution during transplant of hematopoietic stem cells.
Time Frame: 12 months
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
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

EFS CPDL: French Blood Establishment Centre-Pays de la Loire

Investigators

  • Principal Investigator: Patrice CHEVALLIER, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC25_0333
  • ANSM - IDRCB (Other Identifier: 2025-A01929-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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