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RECRUITING
NCT06895473
PHASE2

Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome

Sponsor: OHSU Knight Cancer Institute

View on ClinicalTrials.gov

Summary

This phase II trial tests how well cytarabine (Ara-C), methotrexate, and hydrocortisone given between the spinal cord and the membranes that protect it (intrathecal \[IT\]) works in preventing high-grade immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving chimeric antigen receptor (CAR) T-cell therapy. ICANS is a challenging complication of CAR T-cell therapy that causes neurological effects varying from mild headaches or temporary confusion to hallucinations, swelling in the brain, and seizures. Between 20%-70% of patients receiving CAR T-cell therapy show symptoms of neurotoxicity.

Official title: A Phase 2 Study of Prophylactic IT Chemotherapy to Prevent High-Grade Chimeric Antigen Receptor (CAR) T-Cell-Associated Neurotoxicity Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-06-04

Completion Date

2027-12-31

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo CSF sample collection

DRUG

Cytarabine

Given IT

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Methotrexate

Given IT

DRUG

Therapeutic Hydrocortisone

Given IT

Locations (1)

OHSU Knight Cancer Institute

Portland, Oregon, United States