肿瘤细胞治疗研究
英文原题：NK Cell Infusion for Remission Consolidation in AML: A Phase II Trial
⚠ 该试验的登记信息已有 20 个月未更新， 页面上显示的「尚未开始招募」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 II 期注册临床试验，评估 NK 细胞治疗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 98 例。试验地点：其他 · 阿雷格里港（共 1 个中心）。登记号：NCT06783478。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： * 年龄18–59岁；或60–75岁且10分钟综合老年评估（CGA-10）评分<0.4； * 近期诊断AML；若分子检测发现PML-RARA或遗传学评估检出t(15;17)，确诊为急性早幼粒细胞白血病者不纳入； * 缓解诱导治疗后首次达到完全血液学缓解； * 主要研究者认为适合接受大剂量阿糖胞苷（HDAra-C）巩固化疗； * 过去6个月内无NYHA>III级心力衰竭、急性心肌梗死或不稳定型心绞痛史； * 有生育能力的女性β-HCG检测阴性，并同意从签署知情同意书起至末次治疗后1个月内采取避孕措施； * HIV血清学检测无反应； * 入组前4周内未接受研究性治疗； * 有可用的半相合外周血供者； * 已签署知情同意书。 排除标准： * 年龄<18岁；或年龄60–75岁且CGA-10评分>0.4；或年龄>76岁（不论CGA-10评分）； * 经分子检测发现PML-RARA或遗传学评估检出t(15;17)，确诊急性早幼粒细胞白血病； * 缓解诱导治疗后未能首次达到完全血液学缓解； * 研究者认为不适合接受HDAra-C巩固化疗； * 过去6个月内有NYHA>III级心力衰竭、急性心肌梗死或不稳定型心绞痛史； * 有生育能力女性β-HCG检测阳性，或不遵守从签署知情同意书起至末次治疗后1个月的避孕要求； * HIV血清学检测有反应； * 入组前4周内接受过研究性治疗； * 无可用的半相合外周血供者； * 未签署知情同意书。
Inclusion Criteria: * Male or female patients aged 18 to 59 years, and 60 to 75 years if their score is \< 0.4 on the 10-minute Comprehensive Geriatric Assessment (CGA-10); * Recently diagnosed acute myeloid leukemia, excluding acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation; * In first complete hematologic remission after remission induction; * Eligible, in the opinion of the principal investigator, to undergo consolidation chemotherapy with HDAra-C; * No history of NYHA \> III heart failure, acute myocardial infarction, or unstable angina in the past 6 months; * Negative beta-HCG test for women of childbearing potential and agreement to use contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment; * Non-reactive HIV serology; * No prior investigational therapy in the 4 weeks before study enrollment; * Availability of a haploidentical peripheral blood donor; * Signed informed consent form. Exclusion Criteria: * Patients under 18 years of age; or aged 60 to 75 years with a score \> 0.4 on the CGA-10 scale; or over 76 years of age, regardless of the score on the CGA-10 scale. * Diagnosis of acute promyelocytic leukemia confirmed by the molecular finding of PML-RARA or the presence of t(15:17) in genetic evaluation. * Failure to achieve first complete hematologic remission after remission induction. * Ineligible, in the investigator's opinion, to undergo consolidation chemotherapy with HDAra-C. * History of NYHA \> III heart failure, acute myocardial infarction, or unstable angina in the past 6 months. * Positive beta-HCG test for women of childbearing potential or non-compliance with using contraceptive methods throughout the treatment, from the time of informed consent signature until one month after the last dose of treatment. * Reactive HIV serology. * Prior investigational therapy in the four weeks preceding study enrollment. * Lack of availability of a haploidentical peripheral blood donor. * Failure to sign the informed consent form.
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：Event-free survival (EFS) · 24 months
次要终点：Overall response rate (ORR)；Pre-transplant minimal residual disease (MRD) measurement；Immune Recovery；Chimerism；Depression Scale
输注6次体外扩增并激活的半相合NK细胞，每次1×10⁷个/kg。
输注6次安慰剂。
急性髓系白血病（AML）是一种复杂、进展迅速且死亡率高的疾病。近年来新药研发改善了治疗耐受性并延长生存，但多数病例仍会复发。过继免疫治疗正成为一种新型癌症治疗方式；多项I/II期研究（包括本研究团队的研究）显示，NK细胞具有显著抗白血病活性，尤其针对AML。本研究将评估：在化疗使疾病接近清除时，给予体外扩增和激活的健康供者半相合NK细胞，能否清除残留疾病并延缓或避免复发。本研究为在巴西两个治疗中心开展的随机、优效性、双盲、安慰剂对照临床试验。纳入18–75岁、各风险组、标准治疗后完全缓解的成人AML患者；有骨髓供者且符合条件者可接受造血干细胞移植（HSCT）。研究旨在比较高剂量化疗后立即输注半相合NK细胞与不输注NK细胞，对无事件生存期（EFS）、总生存期（OS）及随访期间或HSCT前微小残留病（MRD）的影响。共98名完全缓解（CR）受试者将随机接受6次1×10⁷个NK细胞/kg输注或6次安慰剂输注。所有受试者均将接受细胞和分子层面的免疫恢复评估，并比较免疫特征以分析细胞应答机制。
Acute Myeloid Leukemia (AML) is a complex and rapidly progressive disease with high mortality. Although significant progress has been made in recent years with the development of new drugs, resulting in better therapeutic tolerability and increased survival, disease relapse occurs in most cases. Adoptive immunotherapy has been increasingly emerging as an innovative alternative for cancer treatment. Among the immune cells tested, natural killer (NK) cells appear to exert significant antileukemic activity, particularly against AML, as demonstrated by numerous phase I/II studies published in the literature, including studies from our group. This study aims to test whether haploidentical NK cells from healthy individuals, expanded and activated in vitro, administered when the disease is nearly eradicated by chemotherapy, can eliminate residual disease, delaying or eliminating the possibility of relapse. It is a randomized, superiority, double-blind, placebo-controlled clinical trial conducted at two treatment centers in Brazil. Adult patients aged 18 to 75 years with AML, from any risk group, in complete remission after completing standard treatment, will be included. Those with a bone marrow donor and eligible for this treatment will be allowed to undergo hematopoietic stem cell transplantation (HSCT). The study's objective is to determine whether the infusion of haploidentical NK cells immediately after high-dose chemotherapy results in increased event-free survival (EFS), overall survival (OS), and lower minimal residual disease (MRD) during follow-up or immediately before HSCT compared to patients undergoing the same treatment without NK cell infusion. A total of 98 participants in complete remission (CR) will be randomized to receive 6 infusions of 1 x 10⁷ NK cells/kg or 6 placebo infusions. All participants will be evaluated for immune recovery at the cellular and molecular levels, and their immune profiles will be compared to analyze cellular response mechanisms.
MEMBER ACCOUNT
登录成功会直接打开下一页。
