肿瘤细胞治疗研究
英文原题：Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
⚠ 该试验的登记信息已有 19 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项分期未标注的注册临床试验，评估细胞治疗用于急性髓系白血病、急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 51 例。试验地点：欧洲 · 佩鲁贾（共 1 个中心）。登记号：NCT06845592。
不限性别 · ≥ 18 Years 且 ≤ 65 Years
纳入标准： AML患者： • 确诊AML且有异基因造血细胞移植指征。 • 确诊为不良遗传风险白血病，或移植时存在MRD或活动性疾病（骨髓浸润5%至30%）。 • 有适合接受G-CSF（10 μg/kg/日，最长7天）治疗且能够耐受至少2次白细胞单采的造血干细胞供者（患者亲属或无关HLA匹配/单倍体相合供者）。 • 年龄≥18岁且≤65岁。 • ECOG评分≤2。 • HCT-CI≤4。 • 无相关精神疾病。 • 已签署知情同意书。 ALL患者： • 确诊T细胞或B细胞（费城染色体阴性）ALL或混合表型白血病，且有异基因移植指征。 • 移植时存在MRD或活动性疾病（骨髓浸润5%至30%），或患者处于第二次及以上血液学完全缓解。 • 有适合接受G-CSF（10 μg/kg/日，最长7天）治疗且能够耐受至少2次白细胞单采的造血干细胞供者（患者亲属或无关HLA匹配/单倍体相合供者）。 • 年龄≥18岁且≤65岁。 • ECOG评分≤2。 • HCT-CI≤4。 • 无相关精神疾病。 • 已签署知情同意书。 排除标准： AML患者： • AML处于完全缓解且MRD阴性。 • AML外周血原始细胞>5%或骨髓浸润≥30%。 • 年龄<18岁或>65岁。 • ECOG评分>2。 • 临床判断存在不可接受的肺、肝、肾和/或心功能，或存在相关精神疾病。 • 妊娠。 • 未签署知情同意书。 ALL患者： • ALL外周血原始细胞>5%或骨髓浸润≥30%。 • 费城染色体阳性ALL。 • 年龄<18岁或>65岁。 • ECOG评分>2。 • 临床判断存在不可接受的肺、肝、肾和/或心功能，或存在相关精神疾病。 • 妊娠。 • 未签署知情同意书。
Inclusion Criteria: * AML patients * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation. * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure. * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) 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 ≤ 65 years * ECOG ≤ 2 * HCT-CI ≤ 4 (51,52) * Absence of relevant psychiatric diseases * Signature of the informed consent ALL patients * Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant * Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure. * Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) 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 ≤ 65 years * ECOG ≤ 2 * HCT-CI ≤ 4 * Absence of relevant psychiatric diseases * Signature of the informed consent Exclusion Criteria: * AML patients * AML in CR MRD- * AML with \> 5% peripheral blasts or bone marrow infiltration ≥ 30% * Age \< 18 years or \> 65 years * ECOG \> 2 * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment * Pregnancy * No signature of the informed consent * ALL patients * ALL with \> 5% peripheral blasts or bone marrow infiltration ≥30% * Philadelphia positive ALL * Age \< 18 years or \> 65 years * ECOG \> 2 * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment * 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 irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched or haploidentical donors in high-risk acute leukemia 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
所有入组患者接受20 Gy TMLI为基础的预处理方案，随后输注供者移植物并进行Treg/Tcon过继免疫治疗。
这是一项单中心介入性研究，评估以放疗为基础的预处理方案联合供者调节性T细胞（Treg）/常规T细胞（Tcon）过继免疫治疗，进行HLA匹配或单倍体异基因移植治疗高危急性白血病患者的疗效。
The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.
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