Clinical trial · Observational
Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia
ENKLA-M : Study of NK Cells in the Monitoring of Patients With Acute Leukemia or Myelodysplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukaemia (Acute Lymphoblastic) | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukaemia (Acute Myeloid) | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples (during routine care) | Other | — | UNRESOLVED |
| Bone marrow sampling (during routine care) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- 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.
- interventionNames
- Other: Bone marrow sampling (during routine care)
- Other: Blood samples (during routine care)
- label
- 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.
- interventionNames
- Other: Bone marrow sampling (during routine care)
- Other: Blood samples (during routine care)
- label
- LAL (Acute lymphoblastic leukaemia)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available