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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03688451

Enrollment

Registered

2018-09-28

Start date

2018-10-29

Completion date

2024-10-01

Last updated

2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Hodgkin Lymphoma

Brief summary

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.

Interventions

DRUGRituximab

Intrathecal administration over 3-5 minutes

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Sequential dose cohorts

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ability to deliver greater than 80% of planned doses	28 months	Percentage of planned doses administered for planned accrual
Related Grade 3 or higher non-hematological toxicity	28 months	Number of related grade 3 or higher non-hematological toxicities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026