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

Tahir Latif

Status and phase: Active, not recruiting; Phase 2

Conditions: Non Hodgkin Lymphoma

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT03688451

UCCI-HEM-17-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intrathecal rituximab

Experimental group

Description:

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

Treatment:

Drug: Rituximab