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

Phase 2

Active, not recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: Rituximab

• Registration Number: NCT03688451
• Lead Sponsor: Tahir Latif

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2018-10-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29
• Primary Completion: 2023-12-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intrathecal rituximab	Rituximab	Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5

Primary Outcome Measures

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

Trial Locations

Locations (1)

UC Health; 🇺🇸 Cincinnati, Ohio, United States