A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 191
- 主要终点
- Progression-Free Survival (PFS) by Independent Review Committee (IRC)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab [for CLL only] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
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 relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive tacabrutideg or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive tacabrutideg versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).
Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either tacabrutideg or the investigator's choice of treatment.
"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 or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- •Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- •Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- •Adequate liver function
- •Adequate blood clotting function
排除标准
- •Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- •Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- •Known central nervous system involvement
- •Prior exposure to any BTK protein degraders
- •Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- •Clinically significant cardiovascular disease
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Arm A: BGB-16673 monotherapy
Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
干预措施: BGB-16673 (Drug)
Arm B: Investigator's Choice
Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
干预措施: Rituximab (Drug)
Arm B: Investigator's Choice
Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
干预措施: Venetoclax (Drug)
Arm B: Investigator's Choice
Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
干预措施: Idelalisib (Drug)
Arm B: Investigator's Choice
Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.
干预措施: Bendamustine (Drug)
Arm A: Tacabrutideg monotherapy
Participants will receive tacabrutideg once daily until any of the treatment discontinuation criteria are met
干预措施: Tacabrutideg (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by Independent Review Committee (IRC)
时间窗: Approximately 36 Months
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
次要结局
- Overall Survival (OS)(Approximately 36 Months)
- Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC(Approximately 36 Months)
- PFS by the Investigator Assessment(Approximately 36 Months)
- Overall Response Rate (ORR) by IRC and Investigator Assessment(Approximately 36 Months)
- Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment(Approximately 36 Months)
- Duration of Response (DOR) by IRC and Investigator Assessment(Approximately 36 Months)
- Time to Next Anti-CLL/SLL Treatment (TTNT)(Approximately 36 Months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Approximately 36 Months)
- 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(Approximately 24 Months)
- Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales(Approximately 24 Months)