An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
2019年12月18日 更新者：AbbVie
An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
This is a Phase 1, open-label, multicenter, extension study.
Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study.
Subjects will receive ABT-199 during this study.
研究概览
研究类型
介入性
注册 (实际的)
11
阶段
- 阶段1
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
-
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Arizona
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Tucson、Arizona、美国、85719-1478
- University of Arizona Arthritis Center /ID# 101359
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock Med Ctr /ID# 92596
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack Univ Med Ctr /ID# 101417
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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 至 99年 (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:
- Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.
Exclusion Criteria:
- Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
- Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
- Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy.
- Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
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 |
|---|---|
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实验性的：ABT-199
ABT-199 monotherapy
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ABT-199 continuous once daily dosing
其他名称：
|
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 |
|---|---|---|
|
Change in cardiac assessment findings
大体时间：Measured from Day 1 up to 6 years after the last subject has enrolled in the study
|
Electrocardiogram and Multi Gated Acquisition Scan and/or Echocardiogram
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Measured from Day 1 up to 6 years after the last subject has enrolled in the study
|
|
Percentage of subjects with adverse events
大体时间：Measured up to 6 years after the last subject has enrolled in the study
|
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
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Measured up to 6 years after the last subject has enrolled in the study
|
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Change in clinical laboratory test results
大体时间：Measured from Day 1 up to 6 years after the last subject has enrolled in the study
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Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies
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Measured from Day 1 up to 6 years after the last subject has enrolled in the study
|
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Number of subjects with adverse events
大体时间：Measured up to 6 years after the last subject has enrolled in the study
|
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
|
Measured up to 6 years after the last subject has enrolled in the study
|
|
Change in physical exam finding, including vital signs
大体时间：Measured from Day 1 up to 6 years after the last subject has enrolled in the study
|
Body temperature, weight, blood pressure, heart rate
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Measured from Day 1 up to 6 years after the last subject has enrolled in the study
|
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
合作者
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)
2013年12月20日
初级完成 (实际的)
2019年12月16日
研究完成 (实际的)
2019年12月16日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月22日
首次发布 (估计)
2013年10月25日
研究记录更新
最后更新发布 (实际的)
2019年12月19日
上次提交的符合 QC 标准的更新
2019年12月18日
最后验证
2019年12月1日
更多信息
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.