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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Minors,

Pregnant and/or breastfeeding women

Adult patients under guardianship,

Protected persons.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bone marrow sampling (during routine care)

    Other intervention

    Bone marrow sample (1 ml)

  • Blood samples (during routine care)

    Other intervention

    3 tubes of 10 ml per visit

Treatment groups

55 Participants
are divided into 3 treatment groups
Group A: AZA/DLI Group2 interventions
Group B: Group without AZA/DLI2 interventions
Group C: LAL (Acute lymphoblastic leukaemia)2 interventions

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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).

Time frame
12 months
2

Assess NK cell reconstitution during transplant of hematopoietic stem cells.

Time frame
12 months
3

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.

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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Nantes University Hospital

Lead sponsor

EFS CPDL: French Blood Establishment Centre-Pays de la Loire

Collaborator

This trial is not recruiting at the moment. You can still explore other options: