Rituximab for Non-Hodgkin Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byTahir Latif, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tahir Latif

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if rituximab can be safely given directly into the spinal fluid along with methotrexate. It targets patients with cancers affecting the central nervous system. Rituximab helps the immune system find and destroy cancer cells, while methotrexate kills them directly.

Research Team

Tahir Latif, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for people with a type of Non-Hodgkin's Lymphoma that has a high risk of spreading to the brain and spinal cord. Participants must be undergoing treatment with rituximab combined with certain chemotherapy regimens (CHOP, CHOEP, or EPOCH) and qualify for preventive therapy in the central nervous system.

Inclusion Criteria

I have a high-risk B-cell lymphoma and am getting rituximab with CHOP, CHOEP, or EPOCH.

Exclusion Criteria

I have had spinal surgery or cannot receive spinal injections.

My cancer is in the brain or has spread to the brain.

Treatment Details

Interventions

Rituximab (Monoclonal Antibodies)

Trial OverviewThe study is testing if injecting rituximab directly into the spinal canal, along with standard chemotherapy drugs like methotrexate, is both doable and safe for patients at high risk of their lymphoma affecting the central nervous system.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Intrathecal rituximabExperimental Treatment1 Intervention

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

Rituximab is already approved in Canada for the following indications: