NCT06714370已完成不适用
Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study
Ono Pharmaceutical Co., Ltd.6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient is ≥ 18 years of age.
- •r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June
- •Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who lacks the capacity to give informed consent.
- •Deceased patients are considered included under an IRB-approved consent waiver.
- •Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received.
- •Histopathologically confirmed large B-cell PCNSL.
- •Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX.
- •Exclude HIV infection
- •Exclude Burkitt lymphoma
- •Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.
排除标准
- 未提供
结局指标
主要结局
Objective response rate (ORR)
时间窗: At least 9 months for each subject
objective response rate is defined as the proportion of subjects who respond either Complete response (CR), Partial response (PR), or unconfirmed Complete response (CRu) to therapy, according to International PCNSL Collaborative Group (IPCG) criteria.
次要结局
- Duration of response (DOR)(At least 9 months for each subject)
- Time-to-treatment response (TTR)(At least 9 months for each subject)
- Adverse events of special interest (AESIs)(At least 9 months for each subject)
- Clinical laboratory test(At least 9 months for each subject)
- Treatment-emergent adverse events (TEAEs)(At least 9 months for each subject)
- Overall survival (OS)(At least 9 months for each subject)
- Progression-free survival (PFS)(At least 9 months for each subject)
研究者
研究点 (6)
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