Chemotherapy Free Treatment With Venetoclax and Obinutuzumab for Relapsed / Refractory Primary CNS Lymphoma Patients (VENOBI-CNS Study) - A Phase IB Study to Assess the Pharmacokinetics in the Cerebrospinal Fluid
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of venetoclax and obinutuzumab
研究概览
简要总结
This is a phase IB study investigating the pharmacokinetics of the combination venetoclax and obinutuzumab in the cerebrospinal fluid of patient with relapsed primary CNS lymphoma.
详细描述
This is a phase IB study investigating the pharmacokinetics of the combination venetoclax and obinutuzumab in the cerebrospinal fluid of patient with relapsed primary CNS lymphoma. Three dosing groups of venetoclax (600mg, 800mg, and 1000mg) are planned; dosing of obinutuzumab will be 1000mg for each dosing group. 15 patients are planned being included from two centers in Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dosing group 2
Venetoclax 800mg + Obinutuzumab 1000mg
干预措施: Venetoclax (Drug)
Dosing group 1
Venetoclax 600mg + Obinutuzumab 1000mg
干预措施: Venetoclax (Drug)
Dosing group 1
Venetoclax 600mg + Obinutuzumab 1000mg
干预措施: Obinutuzumab (Drug)
Dosing group 2
Venetoclax 800mg + Obinutuzumab 1000mg
干预措施: Obinutuzumab (Drug)
Dosing group 3
Venetoclax 1000mg + Obinutuzumab 1000mg
干预措施: Venetoclax (Drug)
Dosing group 3
Venetoclax 1000mg + Obinutuzumab 1000mg
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Pharmacokinetics of venetoclax and obinutuzumab
时间窗: day 3, 15, and 28
Serum concentration and CSF concentration (μg/ml)
次要结局
- Progression-free survival 2 (PFS2)(Up to 12 months)
- Dose limiting toxicities(Within the first 6 weeks)
- Best lymphoma response achieved during induction(During induction (3 months))
- Progression-free survival 1 (PFS1)(Up to 15 months)
- Overall survival(Up to 15 months)
- Mutational landscape of lymphoma(At baseline)