NCT03206970已完成2 期
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
BeiGene13 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2017年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 13
- 主要终点
- Overall Response Rate (ORR) As Assessed By Independent Review Committee
研究概览
简要总结
The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
- •Eastern Cooperative Oncology Group performance status of 0-
- •Measurable disease by computed tomography/magnetic resonance imaging.
- •Received prior regimens for MCL.
- •Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen.
- •Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
- •Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
- •Life expectancy of > 4 months.
排除标准
- •Current or history of central nervous system lymphoma.
- •Prior exposure to a BTK inhibitor before enrollment.
- •Prior corticosteroids with anti-neoplastic intent within 7 days.
- •Major surgery within 4 weeks of screening.
- •Toxicity must have recovered from prior chemotherapy.
- •History of other active malignancies within 2 years of study entry.
- •Currently clinically significant active cardiovascular disease.
- •QT interval corrected with Fridericia's formula > 450 microseconds or other significant electrocardiogram abnormalities.
- •Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
- •Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib
Experimental
Zanubrutinib (160 milligrams) administered orally twice daily
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) As Assessed By Independent Review Committee
时间窗: Up to 1 year and 11 months
The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.
次要结局
- ORR As Assessed By The Investigator(Up to 3 years and 6 months)
- Number Of Participants Experiencing AEs Leading To Treatment Discontinuation(From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months))
- Time To Response(Up to 3 years and 6 months)
- Duration Of Response(Up to 3 years and 6 months)
- Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs)(From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months))
- Progression-free Survival(Up to 3 years and 6 months)
研究者
研究点 (13)
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