Recruiting
Phase 2

Cytarabine, Methotrexate, Hydrocortisone

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06895473

Conditions

Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cytarabine

Lumbar Puncture

Methotrexate

Therapeutic Hydrocortisone

Study Details

Brief summary:

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Study ID

NCT06895473

Start date

Jun 4, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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
  • 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

Study Design

Enrollment

26 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (cytarabine, methotrexate, hydrocortisone)

Patients receive cytarabine IT, methotrexate IT, and hydrocortisone IT over 3-5 minutes via LP on day 4 post-SOC CAR T-cell therapy in the absence of unacceptable toxicity or development of ICANS. Patients who do not develop ICANS of any grade, also receive hydrocortisone IT on day 7 post SOC CAR T-cell therapy. Additionally, patients undergo CSF sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo CSF sample collection

Cytarabine

Given IT

Lumbar Puncture

Undergo lumbar puncture

Methotrexate

Given IT

Therapeutic Hydrocortisone

Given IT

Primary outcome measure

  • Incidence of American Society for Transplantation and Cellular Therapy (ASTCT) ≥ grade 3 immune-effector cell associated neurotoxicity syndrome (ICANS) [ Time Frame: From first dose of intrathecal (IT) chemotherapy (chimeric antigen receptor [CAR]-T day 4) to CAR-T day 30 ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Stephen E. Spurgeon

503-494-8950spurgeos@ohsu.edu

Principal Investigator:

Stephen E. Spurgeon

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-06-26.