NCT07249476

Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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.

Conditions

• Leukaemia (Acute Myeloid)
• Leukaemia (Acute Lymphoblastic)
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-02-01
• Completion: 2030-02-01
• First posted: 2025-11-25
• Last updated: 2025-12-16