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NCT Number: NCT07249476

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Assess NK cell reconstitution during transplant of hematopoietic stem cells.

    Time frame: 12 months

  3. 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

  4. Assess the impact of Donor Lymphocyte Injection used in the prevention of post-allogeneic transplant relapse on NK cells.

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsor department

CONTACT

[email protected]

+33253482835

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ENKLA-M

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Nov 25, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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