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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Non Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Sequential dose cohorts

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intrathecal rituximab

Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Intrathecal administration over 3-5 minutes

Interventions

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Rituximab

Intrathecal administration over 3-5 minutes

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No