NCT05479994进行中（未招募）2 期
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Adult Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
BeiGene50 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 50
- 主要终点
- Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:
- •Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or
- •Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.
- •Participants who require treatment based on the iwCLL 2018 criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2
- •Life expectancy of > 6 month
排除标准
- •Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer
- •Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
- •A known history of or currently suspected Richter's syndrome
- •Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)
- •Prior allogeneic stem cell transplant
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Treatment Arm
Experimental
Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
干预措施: BGB-11417 (Drug)
结局指标
主要结局
Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
时间窗: Up to 2 Years
Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)
次要结局
- Overall Response Rate (ORR) as assessed by the investigator(Up to 2 Years)
- Duration of response (DoR) as determined by the IRC and the investigator(Up to 5 Years)
- Progression Free Survival (PFS) as determined by the IRC and the investigator(Up to 5 Years)
- Time to Response (TTR) as assessed by investigator and IRC(Up to 2 Years)
- Overall Survival (OS)(Up to 5 Years)
- Participants Reported Outcome as measured by EQ-5D-5L questionnaires(Up to 5 Years)
- Participant Reported Outcomes as measured by NFLymSI-18(Up to 5 Years)
- Number of participants with clinically significant changes from baseline in vital signs(Up to 5 Years)
- Number of participants with clinically significant changes from baseline in clinical laboratory values(Up to 5 Years)
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Up to 5 Years)
- Number of Participants With Clinically Significant Physical Examination Findings(Up to 5 Years)
研究者
研究点 (50)
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