跳至主要内容
临床试验/jRCT2071230124
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)

Ono Pharmaceutical Co.,LTD0 个研究点目标入组 20 人开始时间: 2024年5月17日最近更新:

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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