An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 955
- 试验地点
- 305
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up after treatment. Information collected in this study will help health authorities better understand the long-term effects of zanubrutinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Currently participating or participated recently in a BeOne (previously BeiGene) parent study
- •Intent to continue or start zanubrutinib treatment after any of the following:
- •At time of final analysis or study closure of the eligible BeOne (previously BeiGene) parent study
- •At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
- •At an alternative timepoint for an alternative reason
- •Patient who is currently on zanubrutinib treatment:
- •Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
- •Zanubrutinib-naive patient:
- •Must meet the following criteria ≤ 15 days before first dose of study drug:
- •Platelets ≥ 50,000/mm3
- •Absolute neutrophil count ≥ 750/mm3
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
- •Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
- •QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
- •No known New York Heart Association (NYHA) Class III or IV congestive heart failure
- •Creatinine clearance ≥ 30 mL/min
- •Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.
排除标准
- •Permanently discontinued from zanubrutinib treatment in the BeOne (previously BeiGene) parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
- •Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
- •Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
- •Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
- •Pregnant or lactating woman
- •Inability to comply with study procedures
- •Concurrent participation in another therapeutic clinical study
- •History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Zanubrutinib in combination with Tislelizumab
Participants to receive the combination as in the parent study (Australia Only)
干预措施: Tislelizumab (Drug)
Zanubrutinib (BGB-3111)
All participants to receive open-label zanubrutinib
干预措施: Zanubrutinib (Drug)
Zanubrutinib in combination with Tislelizumab
Participants to receive the combination as in the parent study (Australia Only)
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 5 years
Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 5 years
Safety as assessed by incidence of all treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) and according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)
次要结局
- Overall Survival (OS)(Up to 5 years)
- Progression-Free Survival (PFS) per investigator assessment(Up to 5 years)
- Duration of Response (DOR) per investigator assessment(Up to 5 years)
- Progression-Free Survival (PFS)(Up to 5 years)
- Duration of Response (DOR)(Up to 5 years)