2025-522860-34-00招募中3 期
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
BeOne Medicines AG56 个研究点 分布在 10 个国家目标入组 196 人开始时间: 2025年11月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 56
- 主要终点
- PFS, 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 patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL)
研究概览
简要总结
To evaluate the efficacy of BGB-16673 compared to pirtobrutinib as measured by progression-free survival (PFS) determined by independent review committee (IRC)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria.
- •Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
- •Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
排除标准
- •Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation.
- •Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL.
- •History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- •Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or non covalent BTKi (ncBTKi). Patients who discontinue cBTKi due solely to toxicity are not eligible
- •History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
结局指标
主要结局
PFS, 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 patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL)
PFS, 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 patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL)
次要结局
- OS, defined as time from the date of randomization to the date of death due to any cause
- PFS determined by investigator assessment
- Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL
- Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment
- Duration of response determined by IRC and by investigator assessment
- Time to next anti-CLL/SLL treatment (TTNT)
- Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
- Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire IL409 (an itemized version of EORTC quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17)
研究者
BeOne Medicines Clinical Support
Scientific
BeOne Medicines AG
研究点 (56)
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