Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome

Launched by OHSU KNIGHT CANCER INSTITUTE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—cytarabine, methotrexate, and hydrocortisone—given through the spine to see if they can help prevent a serious side effect known as immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving CAR T-cell therapy. ICANS can cause a range of neurological problems, from mild symptoms like headaches to more severe issues such as seizures or confusion. The trial aims to protect patients from these troubling effects, which can occur in 20% to 70% of those treated with CAR T-cell therapy.

To participate in the trial, individuals must be at least 18 years old, be receiving specific CAR T-cell treatments in a hospital, and provide written consent to join. They also need to follow certain guidelines regarding contraception for the first month after treatment, as the effects of these therapies on unborn babies are not fully understood. Participants will undergo monitoring and treatment as part of the study, and they will be excluded if they have certain medical conditions or take specific medications that could interfere with the trial. This research is important as it seeks to improve the safety and effectiveness of CAR T-cell therapies for patients battling blood cancers.

Gender

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Eligibility criteria

• 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 known to all participants that the effects of CAR-T or IT chemotherapy on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use adequate contraception. Should a participant or participant's sexual partner become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• • Platelet count \> 50,000/mm\^3 (μL)
• • Adequate coagulation tests including international normalized ratio (INR) \< 1.6 and fibrinogen \> 100
• Exclusion Criteria:
• • Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
• • History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
• • Known history of hypersensitivity to IT chemotherapy
• * Subject has a contraindication to LP including:
• • Presence of a posterior fossa mass
• • Skin infection near puncture site
• • Uncorrected bleeding diathesis
• • Suspicion of increased intracranial pressure
• • Acute spinal cord trauma
• • Subject is receiving an antiplatelet and/or anticoagulant that cannot be held prior to LP according to best available evidence
• • Known bleeding disorders
• • Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the participant inappropriate for study participation or would put the participant at risk