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Clinical Trials in France / NCT07249476
Starting soon Observational

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

NCT07249476 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06-01
Last updated
2026-06-24

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Bone marrow sampling (during routine care)Blood samples (during routine care)

Bone marrow sampling (during routine care): Bone marrow sample (1 ml)

Blood samples (during routine care): 3 tubes of 10 ml per visit

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Nantes Nantes France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07249476 on ClinicalTrials.gov ↗ ← All trials in France