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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Tahir Latif
Study ID
NCT03688451
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Intrathecal administration over 3-5 minutes

Study Details

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.

Key Dates

Start date
Oct 29, 2018
Status verified
Mar 2023
Primary completion
Dec 1, 2023
Completion
Oct 1, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intrathecal 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 Measure

Ability to deliver greater than 80% of planned doses [ Time Frame: 28 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC HealthCincinnatiOhio45219-

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By research site
UC Health· Cincinnati, OH

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