NCT03846427已完成2 期
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma
BeiGene31 个研究点 分布在 9 个国家目标入组 68 人开始时间: 2019年2月19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
- 68
- 试验地点
- 31
- 主要终点
- Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
研究概览
简要总结
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
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
- •Age 18 years or older
- •Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- •Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
- •Current need for systemic therapy for MZL
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) of 0-2
- •Life expectancy ≥ 6 months
- •Adequate bone marrow function
- •Adequate organ function
- •Male and female participants must use highly effective methods of contraception
排除标准
- •Known transformation to aggressive lymphoma, eg, large cell lymphoma
- •Clinically significant cardiovascular disease
- •Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
- •History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- •History of stroke or intracranial hemorrhage
- •Severe or debilitating pulmonary disease
- •Active fungal, bacterial and/or viral infection requiring systemic therapy
- •Known central nervous system involvement by lymphoma
- •Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- •Major surgery within 4 weeks of the first dose of study drug
- •Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- •Pregnant or lactating women
- •Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
- •Concurrent participation in another therapeutic clinical trial
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib
Experimental
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
时间窗: Up to approximately 3 years and 2.5 months
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the Lugano Classification
次要结局
- ORR by Investigator Assessment(Up to approximately 3 years and 2.5 months)
- Progression-free Survival (PFS) by Investigator Assessment(Up to approximately 3 years and 2.5 months)
- PFS Event-Free Rate by Investigator Assessment(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- Overall Survival (OS)(Up to approximately 3 years and 2.5 months)
- DOR Event-Free Rate by Investigator Assessment(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- Time to Treatment Failure (TTF)(Up to approximately 3 years and 2.5 months)
- Time to Next Line of Therapy(Up to approximately 3 years and 2.5 months)
- Time to Next Line of Therapy Event-Free Rate(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- Area Under the Curve From Time 0 to 6 Hours (AUC0-6)(Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle))
- PFS by IRC Assessment(Up to approximately 3 years and 2.5 months)
- Duration of Response (DOR) by Investigator Assessment(Up to approximately 3 years and 2.5 months)
- Change From Baseline in EuroQol 5-dimension 5-level (EQ-5D-5L) Visual Analogue Score (VAS)(Baseline to Cycle 30 (28 days per cycle))
- Number of Participants With Adverse Events(From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months))
- Elimination Half Life (t1/2)(Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle))
- DOR by IRC Assessment(Up to approximately 3 years and 2.5 months)
- DOR Event-Free Rate by IRC Assessment(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)(Up to approximately 3 years and 2.5 months)
- PFS Event-Free Rate by IRC Assessment(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- OS Event-Free Rate(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- TTF Event-Free Rate(Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported)
- Time to Response (TTR) by Investigator Assessment(Up to approximately 3 years and 2.5 months)
- Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status(Baseline to Cycle 30 (28 days per cycle))
- Apparent Oral Clearance (CL/F) of Zanubrutinib(Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle))
- TTR by IRC Assessment(Up to approximately 3 years and 2.5 months)
- Maximum Observed Concentration (Cmax)(Predose (within 30 min prior to dose) and 0.5, 1, 2, 3, 4, and 6 hours postdose on Cycle 1 Day 1 (28 days per cycle))
研究者
研究点 (31)
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