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.

NCT Number	NCT07249476
Lead Sponsor	Nantes University Hospital Collaborators: EFS CPDL: French Blood Establishment Centre-Pays de la Loire
Conditions	Leukaemia (Acute Myeloid), Leukaemia (Acute Lymphoblastic), Myelodysplastic Syndrome
Enrollment	55 participants
Start Date	2026-06-01
Primary Completion	2029-06-01 (estimated)
Study Completion	2030-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-24