NCT04116437已完成2 期
A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib
BeiGene47 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年10月15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
- 96
- 试验地点
- 47
- 主要终点
- Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
研究概览
简要总结
The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib
- •Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:
- •For ibrutinib and acalabrutinib intolerance events:
- •1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)
- •1 or more ≥ Grade 3 nonhematologic toxicity of any duration
- •1 or more Grade 3 neutropenia with infection or fever of any duration; or
- •Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression.
- •For acalabrutinib intolerance events only;
- •1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or
- •1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or
- •Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use
- •Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor support and platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib
排除标准
- •Clinically significant cardiovascular disease including the following:
- •Myocardial infarction within 6 months before the Screening
- •Unstable angina within 3 months before the Screening
- •New York Heart Association class III or IV congestive heart failure
- •History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
- •QT interval corrected by Fridericia's formula > 480 milliseconds
- •History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
- •History of central nervous system (CNS) hemorrhage
- •Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
- •Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL < 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4 weeks before any Screening assessments are performed
- •Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib
Experimental
Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib
Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
时间窗: 24 months
次要结局
- Overall response as determined by investigator(24 months)
- Progression free survival (PFS) as determined by investigator(24 months)
- Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D)(24 months)
- Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC)(24 months)
- Disease control rate as determined by investigator(24 months)
研究者
研究点 (47)
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