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

Tahir Latif20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Hodgkin Lymphoma

Interventions

RituximabDRUG

Intrathecal administration over 3-5 minutes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC Health

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Ability to deliver greater than 80% of planned doses

Percentage of planned doses administered for planned accrual

Time frame: 28 months

Related Grade 3 or higher non-hematological toxicity

Number of related grade 3 or higher non-hematological toxicities

Time frame: 28 months

Data from ClinicalTrials.gov

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