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

NCT07249476 | Not Yet Recruiting

• 2 other identifiers: RC25_0333ANSM - IDRCB
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

VIDAZA; CSH graft; haematopoietic stem cell; natural killer cells; NK Cells

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Assess the functional potential of different NK cell populations at diagnosis of acute myeloid leukaemia, acute lymphoblastic leukaemia and myelodysplastic syndrome (at each possible relapse of the patient).

  12 months

• Assess NK cell reconstitution during transplant of hematopoietic stem cells.

  12 months

• Assess the impact of the hypomethylating agent AZA used to prevent relapse after allogeneic transplantation for acute myeloid leukaemia or myelodysplastic syndrome on NK cells.

  12 months

• Assess the impact of Donor Lymphocyte Injection used in the prevention of post-allogeneic transplant relapse on NK cells.

  12 months

Study Arms (3)

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.

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

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.

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

LAL (Acute lymphoblastic leukaemia)

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

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

Interventions

Bone marrow sampling (during routine care) OTHER

Bone marrow sample (1 ml)

AZA/DLI Group; Group without AZA/DLI; LAL (Acute lymphoblastic leukaemia)

Blood samples (during routine care) OTHER

3 tubes of 10 ml per visit

AZA/DLI Group; Group without AZA/DLI; LAL (Acute lymphoblastic leukaemia)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients with AML, ALL or MDS treated in the haematology department of Nantes University Hospital. The number of transplants performed for these conditions in the department suggests that 55 patients could be recruited at diagnosis (30 LAM patients, 10 LAL patients and 15 SMD patients). Among the LAM and SMD patients (n=45), we will identify 40 patients for post-transplant studies: \>20 LAM/SMD patients receiving a matched transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group). \>20 LAM/SMD patients receiving a haploidentical transplant: * 10 patients receiving AZA/Donor Lymphocyte Injection for relapse prevention. * 10 patients not receiving AZA/Donor Lymphocyte Injection (control group).

You may qualify if:

• 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.

You may not qualify if:

• Minors,
• Pregnant and/or breastfeeding women
• Adult patients under guardianship,
• Protected persons.

Sponsors & Collaborators

• Nantes University Hospital: lead
• EFS CPDL: French Blood Establishment Centre-Pays de la Loire: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Additional blood and bone marrow samples will only be taken if a blood and/or bone marrow sample is planned during treatment and no additional blood or bone marrow punctures are performed.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia; Myelodysplastic Syndromes

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Patrice CHEVALLIER

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sponsor department

CONTACT

+33253482835; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04