jRCT2031250097招募中不适用
A Phase 3 Randomized Double Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell (BGB-11417-302)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- •Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- •Relapsed or refractory disease after the last line of therapy
- •Measurable disease is defined as at least one nodal lesion with a longest diameter greater than 1.5 cm, or at least one extranodal lesion with a longest diameter greater than 1 cm.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •Adequate organ function
排除标准
- •Prior therapy with B-cell lymphoma-2 inhibitor
- •Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi
- •Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- •Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- •Known central nervous system involvement by lymphoma
- •Clinically significant cardiovascular disease
- •History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
progression free survival (PFS)
To demonstrate superiority of sonrotoclax plus zanubrutinib over placebo plus zanubrutinib as measured by progression free survival (PFS) determined by a blinded independent review committee (BIRC).
次要结局
未报告次要终点
研究者
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