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.
Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions
Age ≥ 18 years. All genders, races, and ethnic groups will be included
Must be receiving SOC Yescarta® or Tecartus® in the inpatient setting
Agree to adhere to institutional guidelines for contraception during the first 30 days post CAR-T
Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
History or presence of CNS disorder such as poorly controlled seizure disorder (seizure within the 12 months), transverse myelitis, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Known history of hypersensitivity to IT chemotherapy
Presence of a posterior fossa mass
OHSU Knight Cancer Institute
Lead sponsor
Oregon Health and Science University
Collaborator
American Society of Clinical Oncology
Collaborator