此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Brentuximab Vedotin 联合环磷酰胺、多柔比星（羟基柔红霉素）、泼尼松（CHP）治疗 CD30 阳性（CD30+）外周 T 细胞淋巴瘤（PTCL）中国参与者的研究

2026年6月11日 更新者：Takeda

Brentuximab Vedotin 联合环磷酰胺、多柔比星（羟基柔红霉素）、泼尼松 (CHP) 一线治疗中国 CD30 阳性 (CD30+) 外周 T 细胞淋巴瘤患者的 2 期、单臂、开放标签、多中心研究(PTCL)

本研究将联合使用 Brentuximab vedotin 和 CHP 治疗患有 CD30+ PTCL 的成年中国参与者。

该研究的主要目的是评估：

  • A+CHP 的副作用
  • 检查随着时间的推移有多少 A+CHP 留在他们的血液中。 这将帮助武田制定出最好的剂量给未来的人们。
  • 如果 A+CHP 改善新诊断的 CD30+ PTCL 的结果

Brentuximab vedotin 将在每个 21 天周期的第 1 天通过静脉给药。 环磷酰胺和多柔比星将通过静脉给药。 第 1 天到第 5 天每天口服泼尼松。

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

在这项研究中被测试的药物被称为 brentuximab vedotin。 正在测试 Brentuximab vedotin 在中国参与者中治疗 CD30+ PTCL。 本研究将研究 A+CHP 作为新诊断 CD30+ PTCL 一线治疗的疗效、安全性和药代动力学 (PK)。

该研究将招募大约 52 名参与者。 参加者将被登记在一个小组中以接收：

• Brentuximab vedotin 1.8 毫克每公斤 (mg/kg) + 环磷酰胺 750 毫克每平方米 (mg/m^2)、多柔比星 50 mg/m^2 和强的松 100 mg

这项多中心试验将在中国进行。 参与本研究的总时间约为 36 个月。

研究类型

介入性

注册 (实际的)

52

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100142
        • Beijing Cancer Hospital
      • Beijing、中国、100191
        • Peking University Third Hospital
      • Changchun、中国、130021
        • The First Hospital of Jilin University
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
      • Chongqing、中国、400030
        • Chongqing University Cancer Hospital
      • Fuzhou、中国、350001
        • Fujian Medical University Union Hospital
      • Guangzhou、中国、510080
        • Guangdong Provincial Peoples Hospital
      • Hangzhou、中国、310003
        • The First Affiliated Hospital of Zhejiang University school of medicine
      • Hefei、中国、230088
        • AnHui Provincial Cancer Hospital
      • Jinan、中国、250117
        • Shandong Cancer Hospital
      • Nanchang、中国、330006
        • The First Affiliated Hospital of Nanchang University
      • Shanghai、中国、200032
        • Fudan University Shanghai Cancer Center
      • Shenyang、中国、110022
        • Shengjing Hospital of China Medical University
      • Suzhou、中国、215004
        • The First Affiliated Hospital of Soochow University
      • Tianjin、中国、300060
        • Tianjin Medical University Cancer Institute & Hospital
      • Zhengzhou、中国、450003
        • Henan Cancer Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 根据 2016 年世界卫生组织 (WHO) 修订版欧美淋巴瘤分类，参与者必须通过当地评估新诊断出 CD30+ PTCL。 必须在入组前提交肿瘤标本，以进行后续的中央病理学审查，以确认组织学（和间变性淋巴瘤激酶 (ALK) 状态，如果适用）和 CD30 表达。 符合条件的组织学包括：

    1. 国际预后指数 (IPI) 评分≥2 的 ALK 阳性全身性间变性大细胞淋巴瘤 (sALCL)。
    2. ALK 阴性 sALCL。
    3. PTCL- 未另行指定 (NOS)。
    4. 血管免疫母细胞性 T 细胞淋巴瘤 (AITL)。
    5. 肠病相关的 T 细胞淋巴瘤 (EATL)。
    6. 肝脾 T 细胞淋巴瘤 (HSTCL)。
  2. 东部肿瘤合作组 (ECOG) 表现状态小于或等于 2。
  3. 通过正电子发射断层扫描 (PET) 成像检测到氟脱氧葡萄糖 (FDG) 狂热性疾病，通过计算机断层扫描 (CT) 检测到具有至少 1 个二维可测量病变（最大尺寸 >1.5 厘米）的可测量疾病。
  4. 适合研究所需血液采样的静脉通路，包括药代动力学 (PK) 和免疫原性采样。

  5. 首次给药前 7 天内筛选/基线时的临床实验室值如下所示：

    1. 总胆红素必须≤正常值上限 (ULN) 的 1.5 倍，或者对于患有吉尔伯特病或有淋巴瘤肝脏受累记录的参与者，总胆红素必须≤正常值上限的 3 倍。
    2. 丙氨酸氨基转移酶 (ALT) 和天冬氨酸氨基转移酶 (AST) 必须≤ULN 的 3 倍或 ULN 的 5 倍，参与者的升高可合理归因于肝脏转移性疾病的存在。
    3. 血清肌酐必须 <2.0 毫克每分升 (mg/dL) 和/或肌酐清除率或计算的肌酐清除率 >40 毫升 (mL)/分钟。
    4. 血红蛋白必须≥8 克每分升 (g/dL)。 （允许在评估前 ≥ 14 天输注红细胞。）
    5. 中性粒细胞绝对计数 >1.5×10^9/升 (L)。
    6. 血小板计数≥75×10^9/L（除非有淋巴瘤的骨髓受累记录）。

排除标准：

  1. 全身抗癌治疗，包括在研究药物首次给药前对研究疾病具有抗肿瘤适应症的中药治疗。
  2. 在研究药物首次给药前 28 天内进行过大手术。
  3. 已知人类免疫缺陷病毒 (HIV) 阳性状态。

  4. 已知乙型肝炎病毒（HBV）表面抗原（HBsAg）血清阳性或活动性丙型肝炎病毒感染。

    注意：HBV 核心抗体阳性且 HBsAg 阴性的参与者可以入选，但必须检测不到 HBV 病毒载量。

  5. 在第一次给药前 3 年内被诊断或治疗另一种恶性肿瘤，或之前被诊断患有另一种恶性肿瘤并且有任何残留疾病的证据。 患有非黑色素瘤皮肤癌或任何类型的原位癌的参与者如果接受了完全切除术，则不会被排除在外。

  6. 在研究药物首次给药前 6 个月内出现以下任何心血管疾病或数值：

    1. 左心室射血分数<45%。
    2. 入组后 6 个月内发生心肌梗塞。
    3. 纽约心脏协会 III 级或 IV 级心力衰竭。
  7. 当前诊断为原发性皮肤 CD30+ T 细胞淋巴增生性疾病和淋巴瘤的参与者。 患有皮肤间变性大细胞淋巴瘤 (ALCL) 且皮肤外肿瘤扩散到局部区域淋巴结之外的参与者符合条件（允许以前的单一药物治疗来解决皮肤和局部区域疾病）。
  8. 蕈样肉芽肿 (MF) [包括转化的 MF] 的参与者。
  9. 不受控制的糖尿病。
  10. 基线周围神经病变≥2 级（美国国家癌症研究所不良事件通用术语标准 [NCI CTCAE]，第 5.0 版）。
  11. 进行性多灶性脑白质病 (PML) 病史。
  12. 既往接受过 brentuximab vedotin 或 CD30 单克隆抗体治疗。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Brentuximab Vedotin + CHP
Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m^2 and doxorubicin 50 mg/m^2 IV, on Day 1 of each 21-day cycle, and prednisone 100 milligram (mg) tablets, orally, on Days 1 through Day 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurs first.
药品：Brentuximab Vedotin
Brentuximab vedotin 静脉输液
药品：环磷酰胺
环磷酰胺静滴
药品：阿霉素
阿霉素静脉输注
药品：强的松
泼尼松片

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma
大体时间：Up to approximately 7 months
ORR by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
大体时间：Up to approximately 7 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment.
Up to approximately 7 months
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
大体时间：Up to approximately 7 months

Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed.

Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Up to approximately 7 months
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)
大体时间：Up to approximately 7 months
Up to approximately 7 months

次要结果测量

结果测量
措施说明
大体时间
CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
大体时间：Up to approximately 7 months
CR rate by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease.
Up to approximately 7 months
1-Year Progression Free Survival (PFS) Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma
大体时间：Month 12
The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
1-Year Overall Survival (OS) Rate
大体时间：Month 12
The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.
Month 12
ORR by IRF Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
ORR by IRF per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
ORR by Investigator Assessment Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
ORR by investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
CR Rate by IRF Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
CR rate by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was defined as the percentage of participants who achieved a CR by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease.
Up to approximately 7 months
CR Rate by Investigator Assessment Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
CR rate by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease
Up to approximately 7 months
Time to Response (TTR) by IRF Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
TTR by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by IRF following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification
大体时间：Up to approximately 7 months
TTR by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by investigator assessment following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Up to approximately 7 months
1-Year PFS Rate by IRF Per 2014 Lugano Classification
大体时间：Month 12
The 1-year PFS rate by IRF per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
1-Year PFS Rate by Investigator Assessment Per 2014 Lugano Classification
大体时间：Month 12
The 1-year PFS rate by investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Month 12
Duration of Response (DOR) by Investigator Assessment Per 2014 Lugano Classification
大体时间：Up to approximately 36 months
DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Up to approximately 36 months
Serum Antibody-Drug Conjugate (ADC) Concentration
大体时间：Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells.
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Plasma Monomethyl Auristatin E (MMAE) Concentration
大体时间：Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs.
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive
大体时间：Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
ADA Titer in Participants Positive for ADA Post Baseline
大体时间：Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.
Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb)
大体时间：Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days
Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Takeda

调查人员

  • 研究主任：Medical Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年2月10日

初级完成 (实际的)

2025年4月27日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2023年1月4日

首先提交符合 QC 标准的

2023年1月4日

首次发布 (实际的)

2023年1月6日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C25024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

武田为符合条件的研究提供去识别化个体参与者数据 (IPD) 的访问权限，以帮助合格的研究人员实现合法的科学目标（武田的数据共享承诺可在 https://clinicaltrials.takeda.com/takedas-commitment?commitment= 5). 这些 IPD 将在数据共享请求获得批准后并根据数据共享协议的条款在安全的研究环境中提供。

IPD 共享访问标准

符合条件的研究的 IPD 将根据 https://vivli.org/ourmember/takeda/ 上描述的标准和流程与合格的研究人员共享 对于获得批准的请求，研究人员将能够访问匿名数据（以根据适用的法律法规尊重患者的隐私）以及根据数据共享协议的条款实现研究目标所需的信息。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅