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

NCT ID: NCT07249476

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2030-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Bone marrow sampling (during routine care)

Intervention Type OTHER

Bone marrow sample (1 ml)

Blood samples (during routine care)

Intervention Type OTHER

3 tubes of 10 ml per visit

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.

Bone marrow sampling (during routine care)

Intervention Type OTHER

Bone marrow sample (1 ml)

Blood samples (during routine care)

Intervention Type OTHER

3 tubes of 10 ml per visit

LAL (Acute lymphoblastic leukaemia)

10 Patients with a (Acute lymphoblastic leukaemia).

This group is monitored at diagnosis only.

Bone marrow sampling (during routine care)

Intervention Type OTHER

Bone marrow sample (1 ml)

Blood samples (during routine care)

Intervention Type OTHER

3 tubes of 10 ml per visit

Interventions

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Bone marrow sampling (during routine care)

Bone marrow sample (1 ml)

Intervention Type OTHER

Blood samples (during routine care)

3 tubes of 10 ml per visit

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

* Minors,
* Pregnant and/or breastfeeding women
* Adult patients under guardianship,
* Protected persons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrice CHEVALLIER

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Central Contacts

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Sponsor department

Role: CONTACT

[email protected]
+33253482835

Other Identifiers

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ANSM - IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

RC25_0333

Identifier Type: -

Identifier Source: org_study_id