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2018年10月29日

适应症Non Hodgkin Lymphoma

干预措施Rituximab

概览

阶段: 2 期
干预措施: Rituximab
疾病 / 适应症: Non Hodgkin Lymphoma
发起方: Tahir Latif
入组人数: 20
试验地点: 1
主要终点: Related Grade 3 or higher non-hematological toxicity
状态: 进行中（未招募）
最后更新: 3年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2018年10月29日

结束日期

2024年10月1日

最后更新

3年前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

Tahir Latif

责任方

Sponsor Investigator

主要研究者

Tahir Latif

Professor of Medicine

University of Cincinnati

入排标准

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.