A Prospective, Multicenter, Real-World Study of Pirtobrutinib in Patients With Mature B-Cell Lymphoma Resistant or Intolerant to Covalent Bruton Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a prospective, multicenter, real-world study to evaluate the efficacy and safety of pirtobrutinib in patients with mature B-cell lymphoma who are resistant or intolerant to prior covalent BTK inhibitors. The primary endpoint is overall response rate (ORR). Secondary endpoints include best overall response (BOR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 40 patients will be enrolled across 8 centers in China.
详细描述
This prospective, multicenter, observational real-world study enrolls 40 patients with histologically confirmed mature B-cell lymphoma who have failed or are intolerant to at least one covalent BTK inhibitor. Patients receive pirtobrutinib 200 mg once daily until disease progression or unacceptable toxicity. Efficacy is assessed per Lugano 2014, iwCLL 2018, and IWWM-11 criteria. Safety is evaluated using CTCAE v5.0. The primary outcome is ORR. Secondary outcomes include BOR, DOR, PFS, OS, and safety profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years;
- •Histopathological confirmation of mature B-cell lymphoma, primarily including CLL/SLL, MCL, FL, MZL, WM/LPL, etc.;
- •Disease progression and/or intolerance after prior treatment with ≥1 cBTKi (including ibrutinib, ibrutinib, zanubrutinib, or acitinib);
- •ECOG PS 0-2;
- •Adequate liver and kidney function: the following criteria must be met simultaneously: 1) AST and ALT ≤ 3×ULN; 2) Total bilirubin ≤ 1.5×ULN; 3) Creatinine clearance rate ≥ 30 mL/min;
- •Participants must be voluntary and capable of completing the study procedures and follow-up examinations;
- •Informed consent must be obtained voluntarily prior to screening.
排除标准
- •Patients with known allergic reactions to any component or excipient of piteutinib;
- •Patients concurrently participating in other clinical studies;
- •A history of clinically significant, uncontrolled cardiac,
- •Cardiovascular disease, or myocardial infarction within 6 months prior to planned initiation of piteutinib therapy;
- •Uncontrolled systemic bacterial, viral, fungal, or parasitic infections; current use of potent CYP3A4 inhibitors or inducers and/or potent P-gp inhibitors;
- •Positive human immunodeficiency virus (HIV) testing;
- •Active hepatitis B or C: 1) Patients with positive hepatitis B virus (HBV) DNA testing and controlled disease status may be enrolled with investigator approval. For HBV DNA-positive patients, concurrent antiviral therapy is required. 2) Patients with prior hepatitis C virus (HCV) infection history who have completed antiviral therapy with viral loads below the quantitative limit may be enrolled;
- •Based on the investigator's assessment, participants may be unable to complete all study protocol requirements, including follow-up visits, and/or adhere to all study procedures;
- •A history of other clinically significant diseases or comorbidities; and any safety risks or potential interference with study completion as evaluated by investigators.
研究组 & 干预措施
Pirtobrutinib Treatment Cohort
Patients with cBTKi-resistant/intolerant mature B-cell lymphoma receiving pirtobrutinib 200 mg once daily in real-world clinical practice.Receive pitobrutinib as monotherapy or in combination, with a recommended dose of 200 mg once daily until disease progression or unacceptable toxicity occurs.
干预措施: Pirtobrutinib (Drug)
结局指标
主要结局
ORR
时间窗: 24months
Overall Response Rate
次要结局
- DOR(24 months)
- BOR(24 months)
- PFS(24 months)
- OS(24 months)
- Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0(24 months)
研究者
Ou Bai, MD/PHD
Principal Investigator, Professor
The First Hospital of Jilin University