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临床试验/NCT07249476
NCT07249476尚未招募不适用

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

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
试验地点
1
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Bone marrow sampling (during routine care) (Other)

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.

干预措施: Blood samples (during routine care) (Other)

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.

干预措施: Bone marrow sampling (during routine care) (Other)

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.

干预措施: Blood samples (during routine care) (Other)

LAL (Acute lymphoblastic leukaemia)

10 Patients with a (Acute lymphoblastic leukaemia).

This group is monitored at diagnosis only.

干预措施: Bone marrow sampling (during routine care) (Other)

LAL (Acute lymphoblastic leukaemia)

10 Patients with a (Acute lymphoblastic leukaemia).

This group is monitored at diagnosis only.

干预措施: Blood samples (during routine care) (Other)

结局指标

主要结局

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.

时间窗: 12 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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