NCT06742996招募中3 期
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
BeOne Medicines272 个研究点 分布在 5 个国家目标入组 300 人开始时间: 2025年3月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 272
- 主要终点
- Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
研究概览
简要总结
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
详细描述
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- •Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
- •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 defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
- •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 (BCL2i)
- •Prior therapy with BTK degraders
- •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. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
- •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.
研究组 & 干预措施
Arm A: sonrotoclax plus zanubrutinib
Experimental
Sonrotoclax and zanubrutinib will be administered in combination.
干预措施: Zanubrutinib (Drug)
Arm B: placebo plus zanubrutinib
Placebo Comparator
Placebo and zanubrutinib will be administered in combination.
干预措施: Zanubrutinib (Drug)
Arm B: placebo plus zanubrutinib
Placebo Comparator
Placebo and zanubrutinib will be administered in combination.
干预措施: Placebo (Drug)
Arm A: sonrotoclax plus zanubrutinib
Experimental
Sonrotoclax and zanubrutinib will be administered in combination.
干预措施: Sonrotoclax (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
时间窗: Approximately 41 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
次要结局
- Overall Survival (OS)(Approximately 92 months)
- PFS as assessed by investigator (INV)(Approximately 58 months)
- Overall Response Rate (ORR) as assessed by BIRC and by INV(Approximately 58 months)
- Duration of Response (DOR) as assessed by BIRC and by INV(Approximately 58 months)
- Complete Response Rate (CRR) as assessed by BIRC and by INV(Approximately 58 months)
- Time to first response as assessed by BIRC and by INV(Approximately 58 months)
- Time to initiation of new anticancer therapy(Approximately 58 months)
- Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)(Approximately 58 months)
- Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)(Approximately 58 months)
- Number of participants with treatment-emergent adverse events (TEAEs)(From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months)
- PFS as assessed by investigator (INV)(Approximately 58 months)
- Overall Response Rate (ORR) as assessed by BIRC and by INV(Approximately 58 months)
- Duration of Response (DOR) as assessed by BIRC and by INV(Approximately 58 months)
- Time to first response as assessed by BIRC and by INV(Approximately 58 months)
- Time to initiation of new anticancer therapy(Approximately 58 months)
- Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)(Approximately 58 months)
- Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)(Approximately 58 months)
- Number of participants with treatment-emergent adverse events (TEAEs)(From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months)
研究者
研究点 (272)
Loading locations...
相似试验
进行中（未招募）
3 期
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)CLLNCT06073821BeOne Medicines652
进行中（未招募）
3 期
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone LymphomaRelapsed/Refractory Follicular LymphomaMarginal Zone LymphomaNCT05100862BeOne Medicines799
进行中（未招募）
3 期
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell TransplantationMantle Cell Lymphoma Non-Hodgkin LymphomaNCT04002297BeOne Medicines510
招募中
2 期
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)NCT05168930Dana-Farber Cancer Institute45
已完成
2 期
Zanubrutinib in Participants With Active Proliferative Lupus NephritisLupus NephritisNCT04643470BeiGene177