A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 630
- 试验地点
- 252
- 主要终点
- Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D
研究概览
简要总结
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- •Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
- •Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- •Adequate organ function
排除标准
- •Known active prolymphocytic leukemia or currently suspected Richter's transformation
- •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 with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
- •Known central nervous system involvement by CLL/SLL
- •Severe or debilitating pulmonary disease
- •Clinically significant cardiovascular disease
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination.
干预措施: Sonrotoclax (Drug)
Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination.
干预措施: Obinutuzumab (Drug)
Arm C: Sonrotoclax plus Obinutuzumab (MRD)
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
干预措施: Obinutuzumab (Drug)
Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination.
干预措施: Venetoclax (Drug)
Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination.
干预措施: Rituximab (Drug)
Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination.
干预措施: Rituximab (Drug)
Arm C: Sonrotoclax plus Obinutuzumab (MRD)
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
干预措施: Sonrotoclax (Drug)
Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab 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) for Arm A versus Arm D
时间窗: Up to approximately 51 months
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
次要结局
- Rate of uMRD4 for Arm A versus Arm D(Up to approximately 12 months)
- Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D(Up to approximately 69 months)
- CRR per BIRC and by INV for Arm B versus Arm D(Up to approximately 25 months)
- Rate of uMRD4 for Arm A versus Arm D(Up to approximately 25 months)
- PFS per Investigator Assessment (INV) for Arm B versus Arm D(Up to approximately 69 months)
- OS for Arm B versus Arm D(Up to approximately 84 months)
- Rate of uMRD4 for Arm B versus Arm D(Up to approximately 25 months)
- PFS per BIRC and by INV for Arm A versus Arm B(Up to approximately 69 months)
- OS for Arm A versus Arm B(Up to approximately 84 months)
- CRR per BIRC and by INV for Arm A versus Arm B(Up to approximately 25 months)
- CRR per INV for Arm A versus Arm D(Up to approximately 25 months)
- PFS per INV for Arm A versus Arm D(Up to approximately 51 months)
- PFS per INV for Arm C versus Arm D(Up to approximately 69 months)
- CRR per INV for Arm C versus Arm D(Up to approximately 25 months)
- OS for Arm C versus Arm D(Up to approximately 84 months)
- Rate of uMRD4 for Arm C versus Arm D(Up to approximately 25 months)
- Overall Response Rate (ORR) per BIRC and by INV(Up to approximately 25 months)
- Time to Response (TTR) per BIRC and by INV(Up to approximately 25 months)
- Time to Next Anti-CLL/SLL Treatment (TTNT)(Up to approximately 84 months)
- Rate of uMRD4(Up to approximately 25 months)
- Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales(Baseline and up to approximately 69 months)
- Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales(Baseline and up to approximately 69 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 of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months)
- Duration of Response (DOR) per BIRC and by INV(Up to approximately 69 months)
- Complete Response Rate as assessed by BIRC for Arm A versus Arm D(Up to approximately 25 months)
- Overall Survival for Arm A versus Arm D(Up to approximately 84 months)
- Rate of uMRD4 for Arm A versus Arm B(Up to approximately 25 months)