肿瘤细胞治疗研究
英文原题：Matched Sibling Allogenic Stem Cell Transplantation With Adoptive Immunotherapy With Regulatory And Conventional T Cells For High Risk Acute Myeloid Leukemia
这是一项 II 期注册临床试验，评估免疫治疗用于急性髓系白血病的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 28 例。试验地点：欧洲 · 佩鲁贾、佩斯卡拉（共 2 个中心）。登记号：NCT07552649。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准：根据ELN 2022建议诊断为具有不良遗传突变的AML，处于完全缓解（CR）或不完全CR（iCR），移植时可伴或不伴MRD阳性；根据ELN 2022诊断为中危遗传学AML，处于CR或iCR且移植时MRD阳性；根据中心政策适合接受清髓性预处理方案的异体造血干细胞移植（allo-HCT）；有合适的家庭HLA匹配造血干细胞供者，供者适合接受G-CSF（10 μg/kg/日，最多7天）并能耐受≥2次白细胞单采；年龄18-70岁；ECOG≤2；HCT-CI≤4；签署知情同意书。排除标准：既往allo-HSCT；具有预后良好遗传学异常的AML；遗传学中危且MRD阴性的AML；移植时有活动性疾病（骨髓浸润>5%）；有半相合供者或匹配无关供者（MUD）；年龄<18岁或>70岁；ECOG>2；经临床判断肺、肝、肾和/或心功能不合格，或存在相关精神疾病；入组时未控制的细菌、病毒或真菌感染；妊娠；未签署知情同意书。
Inclusion Criteria: * Diagnosis of AML with adverse genetic mutations in Complete Remission (CR) or incomplete (i) CR according to ELN 2022 recommendations with or without MRD positivity at the time of the HSCT procedure; * Diagnosis of AML with intermediate genetic mutations in Complete remission (CR) or incomplete (i) CR according to ELN 2022 with MRD positivity at the time of the transplant; * Fitness to undergo allo-HCT with myeloablative conditioning regimens according to center policy; * Availability of a family HLA-matched hematopoietic stem cell donor suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses. * Age ≥ 18 and ≤ 70 years * ECOG ≤ 2 * HCT-CI ≤ 4 * Signature of the informed consent Exclusion Criteria: * Prior allo-HSCT * AML with favorable genetic abnormalities * AML with intermediate genetic risk with MRD negativity * Active disease at transplant (\> 5% bone marrow infiltration) * Availability of a haploidentical or matched unrelated donor (MUD) * Age \< 18 years or \> 70 years * ECOG \> 2 * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment * Uncontrolled bacterial, viral, or fungal infections at time of enrollment * Pregnancy * No signature of the informed consent
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。
主要终点：Number of participants free from disease 2 years after HSCT · The primary objective of the study is to reduce the incidence of disease relapse after myeloablative conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched donors in high-risk AML patients. · 2 years
次要终点：Number of participants that have reached engraftment 45 days after HSCT；Number of participants that developed grade ≥ 2 acute GvHD；Number of participants free from chronic GvHD 2 years after HSCT；Number of participants who died for transplant related mortality after HSCT；Number of patients free from ≥ 2 acute GvHD and/or moderate/severe chronic GvHD and/or relapse；Number of patients free from moderate/severe chronic GvHD and relapse；Number of patients alive after 2 years after allogeneic transplant
所有入组患者接受清髓性预处理，随后输注HLA匹配供者移植物及Treg/Tcon过继免疫治疗。
本研究为多中心介入性研究，评估清髓性预处理联合供者Treg/Tcon过继免疫治疗的HLA匹配异体造血干细胞移植治疗高危急性髓系白血病（AML）患者的疗效。
The study is a multicentric, interventional study that evaluates the efficacy of allogeneic HLA-matched allo-HSCT consisting of myeloablative conditioning coupled with donor Treg/Tcon adoptive immunotherapy for high-risk AML patients.
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