NCT03688451进行中（未招募）2 期
A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma
Tahir Latif1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Related Grade 3 or higher non-hematological toxicity
研究概览
简要总结
The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy.
排除标准
- •Primary central nervous system lymphoma or established secondary central nervous system disease.
- •History of spinal surgery and/or ineligible for intrathecal injections.
研究组 & 干预措施
Intrathecal rituximab
Experimental
Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
干预措施: Rituximab (Drug)
结局指标
主要结局
Related Grade 3 or higher non-hematological toxicity
时间窗: 28 months
Number of related grade 3 or higher non-hematological toxicities
Ability to deliver greater than 80% of planned doses
时间窗: 28 months
Percentage of planned doses administered for planned accrual
次要结局
未报告次要终点
研究者
Tahir Latif
Professor of Medicine
University of Cincinnati
研究点 (1)
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