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

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Leukaemia (Acute Lymphoblastic); Leukaemia (Acute Myeloid); Myelodysplastic Syndrome

Treatments: Other: Blood samples (during routine care); Other: Bone marrow sampling (during routine care)

Study type: Observational

Funder types: Other

Identifiers

NCT07249476

RC25_0333

ANSM - IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

55 participants in 3 patient groups

AZA/DLI Group

Description:

\> 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.

Treatment:

Other: Bone marrow sampling (during routine care)

Other: Blood samples (during routine care)

Group without AZA/DLI

Description:

\> 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.

Treatment:

Other: Bone marrow sampling (during routine care)

Other: Blood samples (during routine care)

LAL (Acute lymphoblastic leukaemia)

Description:

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

Treatment:

Other: Bone marrow sampling (during routine care)

Other: Blood samples (during routine care)