OHSU Knight Cancer Institute
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.
PRIMARY OBJECTIVE: I. To evaluate the efficacy of IT chemotherapy in the prevention of high grade ICANS. SECONDARY OBJECTIVES: I. To evaluate the efficacy of IT chemotherapy in the prevention of any grade ICANS. II. To evaluate safety of IT chemotherapy. III. To evaluate the effect of IT chemotherapy on corticosteroid use. IV. To evaluate the effect of IT chemotherapy on anakinra use. EXPLORATORY OBJECTIVES: I. To evaluate the effect of IT chemotherapy on time to ICANS onset. II. To evaluate the effect of IT chemotherapy on duration of ICANS. III. To evaluate the burden of treatment medi…
Inclusion Criteria: * 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 * Rationale for eligibility criteria based on contraception and pregnancy (both participants and partners of a sperm-producing participant): It shall be k…
Undergo CSF sample collection
Given IT
Undergo lumbar puncture
Given IT
Given IT
Arctuva estimate
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