Spinal injections of cytarabine, methotrexate, and hydrocortisone to prevent severe CAR T neurotoxicity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase II trial delivers a single intrathecal dose of cytarabine, methotrexate, and hydrocortisone via lumbar puncture on day 4 after standard-of-care axi-cel (Yescarta) or brexu-cel (Tecartus), with an additional intrathecal hydrocortisone on day 7 for participants who have not developed ICANS. Cerebrospinal fluid (CSF) samples are collected throughout the study to monitor biological effects, and patients are followed for up to 30 days after treatment. The primary outcome is prevention of high-grade ICANS, with secondary outcomes including prevention of any-grade ICANS, safety, and effects on corticosteroid and anakinra use. Exploratory analyses examine time to ICANS onset, duration of ICANS, and treatment-related serious adverse event burden.

Why it matters

Who can join: the full rules

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, transverse myelitis, 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

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Stephen E Spurgeon — OHSU Knight Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.