Actively Recruiting
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Led by OHSU Knight Cancer Institute · Updated on 2026-01-30
26
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent provided by participant or legally authorized representative
- Age 18 years or older
- Receiving standard of care Yescarta or Tecartus CAR T-cell therapy in an inpatient setting
- Agree to follow contraception guidelines during the first 30 days after CAR T-cell therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Platelet count greater than 50,000 per microliter
- Adequate blood clotting tests including INR less than 1.6 and fibrinogen greater than 100
You will not qualify if you...
- Active or concurrent diagnosis of any central nervous system hematologic cancer
- History or presence of uncontrolled seizure disorder, transverse myelitis, stroke, dementia, cerebellar disease, or autoimmune disease involving the central nervous system
- Known allergy to intrathecal chemotherapy
- Contraindications to lumbar puncture such as posterior fossa mass, skin infection near puncture site, uncorrected bleeding disorder, suspected increased intracranial pressure, or acute spinal cord trauma
- Taking antiplatelet or anticoagulant medications that cannot be stopped before lumbar puncture
- Known bleeding disorders
- Any other significant medical condition that would make participation unsafe or inappropriate according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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