NCT06541665进行中（未招募）1 期
A Multicenter, Phase I, Open-label, Uncontrolled Study of ONO-4059 in Combination With Rituximab, Methotrexate, Procarbazine, and Vincristine (R-MPV) Therapy for Untreated Primary Central Nervous System Lymphoma (PCNSL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 44
- 主要终点
- Tolerability evaluation
研究概览
简要总结
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
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
- •Patients diagnosed with PCNSL
- •Patients who have not received treatment for PCNSL in the past
- •Patients with ECOG Performance Status 0-2
- •Patients expected to survive for 6 months or more
排除标准
- •Patients with intraocular PCNSL without brain lesions
- •Patients are unable to swallow oral medications
研究组 & 干预措施
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental
干预措施: ONO-4059 (Drug)
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental
干预措施: Rituximab (Drug)
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental
干预措施: Methotrexate (Drug)
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental
干预措施: Procarbazine (Drug)
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
Experimental
干预措施: Vincristine (Drug)
结局指标
主要结局
Tolerability evaluation
时间窗: 29 Days
The number of subjects who experienced adverse events and side effects will be tallied. In the tolerability evaluation part, the number of subjects who experienced Dose Limiting Toxicity(DLT) will be tallied
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction
时间窗: 2 years
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.
次要结局
- Duration of response (DOR)(2 years)
- Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing(30days)
- Time to response (TTR)(1 year)
- Complete response rate (CRR)(4 months)
- Best overall response (BOR)(1 year)
研究者
研究点 (44)
Loading locations...
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