A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 510
- 试验地点
- 347
- 主要终点
- Progression-free survival (PFS) determined by independent central review
研究概览
简要总结
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
- •Histologically confirmed diagnosis of MCL
- •No prior systemic treatments for MCL
- •Measurable disease by CT/MRI
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate marrow and organ function
排除标准
- •Known central nervous system involvement by lymphoma
- •Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
- •Clinically significant cardiovascular disease
- •History of severe bleeding disorder
- •Unable to swallow capsules or disease significantly affecting gastrointestinal function
- •Active fungal, bacterial and/or viral infection requiring systemic therapy
- •Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm B: bendamustine plus rituximab
Participants will receive bendamustine plus rituximab, followed by observation.
干预措施: rituximab (Drug)
Arm A: zanubrutinib plus rituximab
Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
干预措施: rituximab (Drug)
Arm B: bendamustine plus rituximab
Participants will receive bendamustine plus rituximab, followed by observation.
干预措施: bendamustine (Drug)
Arm A: zanubrutinib plus rituximab
Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
干预措施: zanubrutinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) determined by independent central review
时间窗: Up to approximately 7 years
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
次要结局
- PFS by investigator assessment(Up to approximately 7 years)
- Overall response rate (ORR)(Up to approximately 7 years)
- Time to Response (TTR)(Up to approximately 7 years)
- Rate of complete response (CR) or complete metabolic response(Up to approximately 7 years)
- Duration of response (DOR)(Up to approximately 7 years)
- Overall survival (OS)(Up to approximately 7 years)
- Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L)(Up to approximately 7 years)
- PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Up to approximately 7 years)
- Number of participants with adverse events and serious adverse events(Up to approximately 7 years)