A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 652
- 试验地点
- 342
- 主要终点
- Cohort 1: Progression Free Survival (PFS）
研究概览
简要总结
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
详细描述
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with CLL without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.
The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
- •Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- •Measurable disease by Computer Tomography/Magnetic Resonance Imaging
- •Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
- •Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
排除标准
- •Previous systemic treatment for CLL
- •Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- •Known central nervous system involvement
- •History of confirmed progressive multifocal leukoencephalopathy (PML)
- •Uncontrolled hypertension
- •Note: Other protocol defined criteria may apply
研究组 & 干预措施
Sonrotoclax Plus Zanubrutinib
Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)
干预措施: Sonrotoclax (Drug)
Venetoclax Plus Obinutuzumab
Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)
干预措施: Venetoclax (Drug)
Venetoclax Plus Obinutuzumab
Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)
干预措施: Obinutuzumab (Drug)
Sonrotoclax Plus Zanubrutinib
Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Cohort 1: Progression Free Survival (PFS）
时间窗: Up to approximately 9 years
PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by independent review committee (IRC)
Cohort 1: Rate of Undetectable Measurable Residual Disease
时间窗: Up to one and a half years
Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.
次要结局
- Pooled Cohorts: PFS by IRC and Investigator Assessment(Up to approximately 9 years)
- Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment(Up to approximately 9 years)
- Cohort 1: Complete Response Rate (CRR ) by IRC(Up to approximately 9 years)
- Cohort 1: Overall Survival (OS)(Up to approximately 9 years)
- Cohort 1: PFS by Investigator Assessment(Up to approximately 9 years)
- Cohort 1: CRR by Investigator Assessment(Up to approximately 9 years)
- Cohort 1: Rate of Undetectable Measurable Residual Disease(Up to approximately 9 years)
- Cohort 1: Overall Response Rate (ORR) by IRC and Investigator Assessment(Up to approximately 9 years)
- Pooled Cohorts: ORR by IRC and Investigator Assessment(Up to approximately 9 years)
- Pooled Cohorts: DOR by IRC and Investigator Assessment(Up to approximately 9 years)
- Pooled Cohorts: Rate of Undetectable Measurable Residual Disease(Up to approximately 9 years)
- Pooled Cohorts: CRR by IRC and Investigator Assessment(Up to approximately 9 years)
- Cohort 1 and Pooled Cohorts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to one and a half years for Sonrotoclax Plus Zanubrutinib group and 13 months for Venetoclax Plus Obinutuzumab group])
- Cohort 1 and Pooled Cohorts: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales(Every three cycles during the treatment period)
- Cohort 1 and Pooled Cohorts: Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales(Every three cycles during the treatment period)
- Cohort 1 and Pooled Cohorts: Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire （EQ-5D-5L) Visual Analogue Scale (VAS).(Every three cycles during the treatment period)