jRCT2071230124进行中(未招募)不适用
ONO-4059-13: 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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 主要终点
- tolerability
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
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
- •1.Patients with intraocular PCNSL without brain lesions
- •2.Patients are unable to swallow oral medications
结局指标
主要结局
tolerability
To confirm the tolerability of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients
safety
To confirm the safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients
次要结局
- Pharmacokinetics of ONO-4059
- Efficacy of ONO-4059
研究者
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