Clinical Trials /

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

NCT03688451

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
  • 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 IDs

  • ORG STUDY ID: UCCI-HEM-17-01
  • NCT ID: NCT03688451

Conditions

  • Non Hodgkin Lymphoma

Interventions

DrugSynonymsArms
RituximabIntrathecal rituximab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intrathecal rituximabExperimentalCohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
  • Rituximab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Ability to deliver greater than 80% of planned doses
Time Frame:28 months
Safety Issue:
Description:Percentage of planned doses administered for planned accrual

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tahir Latif

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