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Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Sponsor: OHSU Knight Cancer Institute
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
Biospecimen Collection
Undergo CSF sample collection
Cytarabine
Given IT
Lumbar Puncture
Undergo lumbar puncture
Methotrexate
Given IT
Therapeutic Hydrocortisone
Given IT
Locations (1)
OHSU Knight Cancer Institute
Portland, Oregon, United States