Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC Health

Cincinnati, Ohio, 45219, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Primary central nervous system lymphoma or established secondary central nervous system disease.
History of spinal surgery and/or ineligible for intrathecal injections.

Treatment and study plan

Rituximab

Drug

Intrathecal administration over 3-5 minutes

Primary outcomes

Ability to deliver greater than 80% of planned doses

Time frame: 28 months

Percentage of planned doses administered for planned accrual
Related Grade 3 or higher non-hematological toxicity

Time frame: 28 months

Number of related grade 3 or higher non-hematological toxicities

Sponsors and collaborators

Lead sponsor

Tahir Latif

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2024
First posted: Sep 28, 2018
Registry last updated: Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting