简要介绍
这是一项分期未标注的注册临床试验,评估细胞治疗用于骨髓增生异常综合征的安全性、可行性及初步疗效。当前状态:尚未开始招募。计划入组 55 例。试验地点:欧洲 · 南特(共 1 个中心)。登记号:NCT07249476。
入组条件决定能不能参加
不限性别 · ≥ 18 Years
纳入标准:成年AML、ALL或MDS患者;接受造血干细胞(HSC)移植的成人;移植后接受或未接受AZA治疗的成人;已签署同意书;参加社会保障体系。
排除标准:未成年人;妊娠或哺乳期女性;受监护的成年人;受法律保护者。
核对登记原文(英文)
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.
以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。
研究终点衡量什么算有效
- 主要终点界定NK细胞介导抗白血病反应相关的KIR和HLA遗传标志12个月
- 次要终点评估AML、ALL和MDS确诊时及患者每次可能复发时不同NK细胞群体的功能潜能
- 次要终点评估造血干细胞移植期间NK细胞重建情况
- 次要终点评估异基因移植后用于预防AML或MDS复发的去甲基化药物AZA对NK细胞的影响
- 次要终点评估用于预防异基因移植后复发的供者淋巴细胞输注对NK细胞的影响
核对登记原文(英文)
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. · 12 months
次要终点: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).;Assess NK cell reconstitution during transplant of hematopoietic stem cells.;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.;Assess the impact of Donor Lymphocyte Injection used in the prevention of post-allogeneic transplant relapse on NK cells.
研究设计怎么做的
- 研究类型
- 观察性研究
- 入组人数
- 55 人(预计)
核对分组登记原文(英文)
- 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.
- 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.
- LAL (Acute lymphoblastic leukaemia) · 10 Patients with a (Acute lymphoblastic leukaemia).
This group is monitored at diagnosis only.
关键日期
- 开始日期
- 2026-06-01
- 主要完成日期
- 2029-06-01
- 全部完成日期
- 2030-06-01
- 登记状态核实于
- 2026-04
联系与责任方
- 申办方
- Nantes University Hospital
- 合作方
- EFS CPDL: French Blood Establishment Centre-Pays de la Loire
- 联系邮箱
- bp-prom-regl@chu-nantes.fr
- 联系电话
- +33253482835
登记简述
ENKLA-M研究采集急性髓系白血病(AML)、急性淋巴细胞白血病(ALL)和骨髓增生异常综合征(MDS)患者样本,研究原始细胞表型(NK受体配体和黏附分子)的演变及患者NK细胞生物学特征。研究在诊断时采集血液和骨髓,分析ALL/AML原始细胞表型及NK细胞表型;并在第30、60、90天、6个月和1年研究NK细胞谱系动态,重点刻画健康人中对抗白血病效力较强的NK细胞群体的表型和转录组。研究还评估阿扎胞苷(AZA)及供者淋巴细胞输注(DLI)对移植患者NK细胞的影响。结合临床数据及KIR/HLA遗传特征,分析NK细胞表型和功能数据,以明确NK细胞与白血病细胞的关键分子相互作用、造血重建期NK细胞抗白血病效力标志,以及AZA/DLI是否通过KIR-HLA相互作用增强NK细胞功能、改善其对残留病灶的控制。
核对登记原文(英文)
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.