Study on Using Intrathecal Cytarabine, Methotrexate, and Hydrocortisone to Prevent Severe Neurotoxicity in CAR T-Cell Therapy

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06895473

Provider View

This clinical trial is testing a combination of drugs given directly into the spinal fluid to prevent severe neurological side effects in patients undergoing CAR T-cell therapy, a treatment for certain cancers. These side effects can range from mild confusion to serious brain swelling and seizures.

Patient Parameters

Program Overview

The purpose of this study is to see if a combination of drugs—cytarabine, methotrexate, and hydrocortisone—given directly into the spinal fluid can prevent severe neurological side effects in patients receiving CAR T-cell therapy. These side effects, known as ICANS, can cause symptoms from mild headaches to serious brain issues like swelling and seizures. The study aims to find out if this drug combination can effectively prevent these side effects, which affect 20% to 70% of patients undergoing CAR T-cell therapy.

Description

The main goal of this study is to test if giving cytarabine, methotrexate, and hydrocortisone directly into the spinal fluid can prevent severe neurological side effects in patients receiving CAR T-cell therapy. These side effects, called ICANS, can range from mild confusion to serious brain swelling and seizures.

Secondary goals include checking if this treatment can prevent any level of ICANS, ensuring the treatment is safe, and seeing how it affects the use of other medications like corticosteroids and anakinra.

The study will also explore how this treatment affects the timing and duration of ICANS and any serious side effects caused by the treatment.

Participants will receive the drugs through a lumbar puncture (a procedure to access the spinal fluid) on days 1 and 5 after starting their standard CAR T-cell therapy. They will also have spinal fluid samples taken throughout the study. After finishing the treatment, participants will be monitored for up to 30 days.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Age 18 or older, open to all genders, races, and ethnicities.
  • Currently receiving standard CAR T-cell therapy (Yescarta or Tecartus) in a hospital setting.
  • Agree to use contraception during the first 30 days after CAR T-cell therapy to prevent pregnancy, as the effects on a developing fetus are unknown.
  • Have a performance status score of 2 or less, meaning they are able to carry out light work or are fully active.
  • Have a platelet count greater than 50,000 per microliter.
  • Have normal blood clotting tests, with an INR less than 1.6 and fibrinogen greater than 100.

Exclusion Criteria

  • Have an active or concurrent diagnosis of any blood cancer affecting the central nervous system.
  • Have a history or current presence of a central nervous system disorder, such as seizures, stroke, dementia, or autoimmune disease affecting the brain.
  • Have a known allergy to the drugs used in the study.
  • Have conditions that prevent safe lumbar puncture, such as:
    • A mass in the back of the brain.
    • Skin infection near the puncture site.
    • Uncontrolled bleeding disorder.
    • Suspected increased pressure in the brain.
    • Recent spinal cord injury.
  • Are taking blood thinners that cannot be stopped before the lumbar puncture.
  • Have known bleeding disorders.
  • Have any other significant medical condition that would make participation unsafe or inappropriate, as judged by the study doctor.

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