NCT07516093招募中3 期
A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 620
- 试验地点
- 6
- 主要终点
- Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
研究概览
简要总结
The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Adequate organ and bone marrow function
- •Confirmed diagnosis of CLL/SLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment
- •Received at least 1 prior line of therapy for CLL/SLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi
- •Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL
排除标准
- •Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment
- •Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment
- •Ongoing systemic corticosteroids ≥10 mg/day prednisone or equivalent
- •Previously treated with a BTK degrader or a noncovalent BTKi
- •Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment
- •Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment
- •Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.
研究组 & 干预措施
Arm B: Pirtobrutinib
Experimental
干预措施: Pirtobrutinib (Drug)
Arm A: NX-5948
Experimental
干预措施: NX-5948 (Drug)
结局指标
主要结局
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
时间窗: Up to approximately 3.5 years
Time from randomization to disease progression per 2018 International Workshop on CLL (iwCLL) or death due to any cause, whichever is earlier
Objective response rate (ORR) without partial response with lymphocytosis (PR-L) as assessed by IRC
时间窗: Up to approximately 2.5 years
Percentage of participants with best overall response of complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), or nodular PR, as assessed per 2018 iwCLL guidelines
次要结局
- Overall survival(Up to approximately 7 years)
- PFS as assessed by the investigator(Up to approximately 3.5 years)
- Objective response rate (ORR) with and without partial response with lymphocytosis (PR-L) as assessed by IRC and investigator(Up to approximately 3.5 years)
- Duration of response with and without PR-L as assessed by IRC and investigator(Up to approximately 3.5 years)
- Time to next anti-CLL/SLL treatment as assessed by IRC and by investigator(Up to approximately 3.5 years)
- Change from baseline in global health status/quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire C30 with CLL module (EORTC QLQ-C30-CLL17)(Baseline and up to approximately 3.5 years)
- Change from baseline in EuroQol-5 Dimensions, 5-level Questionnaire (EQ-5D-5L)(Baseline and up to approximately 3.5 years)
- Number of participants with treatment-emergent adverse events(Up to approximately 3.5 years)
- Pharmacokinetic profile of NX-5948(Up to Cycle 13 Day 1 (each cycle is 28 days))
- Number of participants with clinically significant changes from baseline in laboratory parameters(Up to approximately 3.5 years)
- Number of participants with clinically significant changes from baseline in vital signs(Up to approximately 3.5 years)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
3 期
A 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.2025-522860-34-00BeOne Medicines AG196
招募中
3 期
ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLLCLLNCT07342478Newave Pharmaceutical Inc306
尚未招募
2 期
Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT07690891Medical College of Wisconsin30
尚未招募
2 期
Pirtobrutinib+Sonrotoclax（PS) Regimen in the Treatment of B-Cell LymphomaDLBCL - Diffuse Large B Cell LymphomaCLL / SLLMZLRichter TransformationNCT07744750Changzhou No.2 People's Hospital40
尚未招募
3 期
A study to examine usefulness and safety of remibrutinib in patients with generalized myasthenia gravis.CTRI/2025/07/092102Novartis Healthcare Pvt Ltd180