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NCT03688451 Clinical Trial

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

Non Hodgkin Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03688451
Other study ID # UCCI-HEM-17-01
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 29, 2018
Est. completion date October 1, 2024

Study information
Verified date March 2023
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date October 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rituximab
Intrathecal administration over 3-5 minutes

Locations
Country Name City State
United States UC Health Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Tahir Latif

Country where clinical trial is conducted

United States, 

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