← 返回临床试验

噻替哌、环磷酰胺和白消安联合预处理后异体造血干细胞移植治疗NK/T细胞淋巴瘤

英文原题:Preconditioning With a Combination of Thiotepa, Cyclophosphamide, and Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of NK/T-Cell Lymphoma

ClinicalTrials.gov 2025/12/11(首次登记) II 期注册临床试验 · 尚未开始招募

简要介绍

这是一项 II 期注册临床试验,评估细胞治疗用于淋巴瘤的安全性、可行性及初步疗效。当前状态:尚未开始招募。计划入组 37 例。登记号:NCT07276737。

入组条件决定能不能参加

不限性别 · ≥ 18 Years 且 ≤ 70 Years

纳入标准:年龄18-70岁,性别不限;经组织病理或流式细胞术诊断NK/T细胞淋巴瘤:III/IV期患者经一线或挽救治疗达到缓解;II期患者挽救治疗后复发/难治但达到缓解;NK细胞淋巴瘤/白血病患者一线或挽救治疗后达到缓解;或复发/难治性疾病。须有合适造血干细胞供者:亲属供者在HLA-A、-B、-C、-DQB1和-DRB1位点至少5/10匹配;无关供者至少8/10匹配。HCT特异性合并症指数(HCT-CI)≤2;ECOG 0-2分;肝肾、心肺功能符合:血清肌酐≤正常值上限1.5倍;射血分数≥50%;基础血氧饱和度>92%;总胆红素≤正常值上限1.5倍,ALT和AST≤2倍;肺功能DLCO(血红蛋白校正)≥40%且FEV1≥50%;能够理解并愿意参加研究,签署知情同意书。排除标准:对噻替哌、环磷酰胺或白消安及其成分过敏;任何不稳定系统性疾病,包括不稳定型心绞痛、筛查前3个月内脑血管意外或短暂性脑缺血、筛查前3个月内心肌梗死、NYHA≥III级充血性心力衰竭、需药物治疗的严重心律失常、肝肾或代谢性疾病、肺动脉高压;活动性未控制感染(与感染相关的血流动力学不稳定、感染症状/体征恶化、新发影像学感染灶,或原因未明且未排除感染的持续发热);≥2级癫痫、瘫痪、失语、新发脑梗死、严重脑外伤、痴呆、帕金森病或精神分裂症;HIV感染;需抗病毒治疗的活动性HBV或HCV感染,或HBsAg/乙肝核心抗体阳性且未接受抗乙肝病毒治疗、存在HBV再激活风险;妊娠或哺乳;有生育能力者不愿在治疗期间及治疗后12个月内避孕;研究者判定不宜入组的其他情况。
核对登记原文(英文)
Inclusion Criteria:

1\. Age range: 18-70 years old, gender not restricted. 2. Patients diagnosed with NK/T cell lymphoma through histopathology or flow cytometry, 1) with stage III/IV patients receiving first-line or salvage treatment and achieving remission, 2) stage II patients with relapsed/refractory disease after salvage treatment achieving remission, 3) patients with NK cell lymphoma/leukemia receiving first-line or salvage treatment and achieving remission, 4) patients with relapsed/refractory disease. 3. Patients must have a suitable hematopoietic stem cell donor. 1) The related donor must have at least 5/10 HLA-A, -B, -C, -DQB1, and -DRB1 matching. 2) The unrelated donor must have at least 8/10 HLA-A, -B, -C, -DQB1, and -DRB1 matching. 4. HCT-specific comorbidity index score (HCT-CI) \<= 2. 5. ECOG: 0-2 points. 6. Liver and kidney functions, as well as heart and lung functions, must meet the following requirements: 1) Serum creatinine \<= 1.5 × ULN; 2) Cardiac function: Ejection fraction \>= 50%; 3) Basal oxygen saturation \> 92%; 4) Total bilirubin \<= 1.5 × ULN; ALT and AST \<= 2.0 × ULN; 5) Pulmonary function: DLCO (hemoglobin corrected) \>= 40% and FEV1 \>= 50%. 7. Patients must be capable of understanding and willing to participate in this study, and sign the informed consent form.

Exclusion Criteria:

1\. Patients allergic to stietap, cyclophosphamide or busulfan or its components. 2. Any unstable systemic diseases: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;patients with pulmonary hypertension. 3. Active and uncontrolled infections: hemodynamic instability related to infection, or new symptoms or signs of infection worsening, or new infection lesions found on imaging, persistent fever without exclusion of infection without symptoms or signs; 4. Grade 2 or higher epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson's disease, schizophrenia 5. HIV-infected patients; 6. Patients with active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral treatment; 2.patients with a risk of HBV activation, referring to those with positive hepatitis B surface antigen or core antibody but not receiving anti-hepatitis virus treatment; 7. Pregnant or lactating women; 8. Male and female individuals with reproductive capacity who are unwilling to use contraceptive methods during treatment and within 12 months after treatment; 9. Patients whose study investigators assess have other inadvisable inclusion conditions.

\-

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

  • 主要终点无进展生存期移植后2年。
  • 次要终点复发累积发生率
  • 次要终点急性移植物抗宿主病(GVHD)发生率
核对登记原文(英文)

主要终点:progression free survival · Two years after the transplantation
次要终点:Cumulative recurrence rate;Incidence of acute GVHD

研究设计怎么做的

研究类型
干预性研究
入组人数
37 人(预计)
分组方式
不适用(单臂)
  • 治疗组实验性
核对分组登记原文(英文)
  • treatment group · EXPERIMENTAL

关键日期

开始日期
2025-12-30
主要完成日期
2029-12-30
全部完成日期
2029-12-30
登记状态核实于
2025-11

联系与责任方

主要研究者
Xianmin Song, MD
申办方
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
联系邮箱
shongxm@139.com
联系电话
+86 189 1802 9692

登记简述

评估噻替哌联合环磷酰胺和白消安作为异体造血干细胞移植(allo-HSCT)前预处理方案治疗NK/T细胞淋巴瘤的疗效和安全性。

核对登记原文(英文)

Evaluation of the efficacy and safety of Thiotepa combined with Cyclophosphamide and Busulfan as conditioning regimen before allo-HSCT for the treatment of NK/T cell lymphoma

登记原文与核验信息

试验登记号
NCT07276737
试验期别
II 期
试验状态
尚未开始招募
适应症(原文)
NK T-Cell Lymphoma
干预方式(原文)
Thiotepa