An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Change in clinical laboratory test results
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).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).
研究组 & 干预措施
ABT-199
ABT-199 monotherapy
干预措施: ABT-199 (Drug)
结局指标
主要结局
Change in clinical laboratory test results
时间窗: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
Chemistry, coagulation, hematology, lymphocyte enumeration, paraproteins, urinalysis, and, if appropriate, viral polymerase chain reaction and viral serologies
Number of subjects with adverse events
时间窗: 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
Change in cardiac assessment findings
时间窗: 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
Percentage of subjects with adverse events
时间窗: 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
Change in physical exam finding, including vital signs
时间窗: Measured from Day 1 up to 6 years after the last subject has enrolled in the study
Body temperature, weight, blood pressure, heart rate
次要结局
未报告次要终点