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。

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

2016年10月14日 更新者：Seagen Inc.

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

176

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

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-3300
        • University of Alabama at Birmingham
    • California
      • Duarte、California、美国、91010-3000
        • City of Hope
      • Oxnard、California、美国、93030
        • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
      • Stanford、California、美国、94305-5821
        • Stanford Cancer Center
    • Colorado
      • Aurora、Colorado、美国、80012
        • Rocky Mountain Cancer Centers - Aurora
      • Denver、Colorado、美国、80218
        • Colorado Blood Cancer Institute
    • Florida
      • St. Augustine、Florida、美国、32086
        • Cancer Specialists of North Florida - St. Augustine
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory Winship Cancer Institute
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Minneapolis、Minnesota、美国、55404
        • Minnesota Oncology Hematology P.A.
    • Missouri
      • St. Louis、Missouri、美国、63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas、Nevada、美国、89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Hackensack、New Jersey、美国、07601
        • Hackensack University Medical Center
    • New York
      • Albany、New York、美国、12206
        • New York Oncology Hematology, P.C.
      • New York、New York、美国、10016
        • Nyu Clinical Cancer Center
      • New York、New York、美国、10021
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10019
        • Columbia University Medical Center
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic, The
    • Oregon
      • Eugene、Oregon、美国、97401
        • Willamette Valley Cancer and Research / USOR
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina
      • Greenville、South Carolina、美国、29605
        • St. Francis Hospital
    • Texas
      • Dallas、Texas、美国、75230
        • Texas Oncology - Medical City Dallas
      • Dallas、Texas、美国、75246
        • Charles A. Sammons Cancer Center
      • Fort Worth、Texas、美国、76132
        • Texas Oncology-Southwest Fort Worth
      • Houston、Texas、美国、77030-4003
        • MD Anderson Cancer Center / University of Texas
      • Round Rock、Texas、美国、78665
        • Texas Oncology - Seton Williamson
      • Tyler、Texas、美国、75702
        • Texas Oncology - Tyler
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Edmonds、Washington、美国、98026
        • Swedish Cancer Institute Medical Oncology
      • Seattle、Washington、美国、98109
        • Seattle Cancer Care Alliance / University of Washington Medical Center
      • Vancouver、Washington、美国、98684
        • Northwest Cancer Specialists, P.C.

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

6年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologically-confirmed NHL (DLBCL only for Parts B and C)
  • Relapsed or refractory disease following at least 1 prior systemic therapy
  • Measurable disease of at least 1.5 cm as documented by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  • B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  • Known cerebral/meningeal disease

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：非随机化
  • 介入模型：并行分配
  • 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
药品：brentuximab vedotin
1.8 mg/kg 每 3 周一次静脉输注
其他名称：
  • ; SGN-35
实验性的：Brentuximab vedotin+rituximab
药品：brentuximab vedotin
1.8 mg/kg 每 3 周一次静脉输注
其他名称：
  • ; SGN-35
药品：rituximab
375 mg/m2 every 3 weeks by IV infusion

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
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy
大体时间：Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab
大体时间：Up to 3 years
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Up to 3 years

次要结果测量

结果测量
措施说明
大体时间
Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab
大体时间：Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Complete Remission (CR) Rate by Investigator
大体时间：Up to approximately 3 years
Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
大体时间：Up to approximately 3 years
Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
大体时间：Up to approximately 3 years
Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Up to approximately 3 years
Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis
大体时间：Up to approximately 3 years
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Up to approximately 3 years
Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression
大体时间：Up to 3 years
Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).
Up to 3 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy
大体时间：Up to 3 years
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Up to 3 years
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)
大体时间：1 day
End of infusion concentration of ADC following the first dose of brentuximab vedotin
1 day
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)
大体时间：3 weeks
Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)
大体时间：3 weeks
Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
大体时间：3 weeks
Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
3 weeks
Baseline Soluble CD30 Expression
大体时间：Baseline
Serum concentration of soluble CD30 before first dose of brentuximab vedotin
Baseline

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

Seagen Inc.

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。

一般刊物

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

2011年8月1日

初级完成 (实际的)

2015年6月1日

研究完成 (实际的)

2015年6月1日

研究注册日期

首次提交

2011年8月19日

首先提交符合 QC 标准的

2011年8月19日

首次发布 (估计)

2011年8月23日

研究记录更新

最后更新发布 (估计)

2016年11月28日

上次提交的符合 QC 标准的更新

2016年10月14日

最后验证

2015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

  • SGN35-012

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.

淋巴瘤，B细胞的临床试验

brentuximab vedotin的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Uruguay

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅