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

Sponsor
Nantes University Hospital
Study ID
NCT07249476
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Nov 25, 2025
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: LAL (Acute lymphoblastic leukaemia)
    10 Patients with a (Acute lymphoblastic leukaemia). This group is monitored at diagnosis only.

Primary Outcome Measure

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 ]

Central Contacts

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