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NCT06895473 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Hematopoietic and Lymphatic System Neoplasm, sponsored by OHSU Knight Cancer Institute.

Recruiting
Registry status
Phase 2
Development phase
26
Enrollment target
1
Study location

NCT06895473 is a Phase 2 study of Hematopoietic and Lymphatic System Neoplasm that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 26 participants, below the 483-participant average among 62 other Hematopoietic and Lymphatic System Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06895473, a Phase 2 study of Hematopoietic and Lymphatic System Neoplasm, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.

RECRUITING
Registry status
Phase 2
Development phase
26 participants
Enrollment target
1
Study location

Study 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 Studied

Hematopoietic and Lymphatic System Neoplasm

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Lumbar Puncture
  • DRUG Cytarabine
  • DRUG Methotrexate
  • DRUG Therapeutic Hydrocortisone

Study Locations (1)

Oregon

  • OHSU Knight Cancer Institute - Portland

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2025-06-04
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

OHSU Knight Cancer Institute

211 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06895473

The ClinicalTrials.gov registry entry for NCT06895473 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 62 other Hematopoietic and Lymphatic System Neoplasm trials with a reported enrollment target (95% lower). The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hematopoietic and Lymphatic System Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06895473 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT06895473 about?

NCT06895473 is a clinical study titled "Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome". 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...

What is the current status of trial NCT06895473?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2025-06-04. Estimated completion is 2027-12-31.

What conditions does trial NCT06895473 study?

This clinical trial studies the following conditions: Hematopoietic and Lymphatic System Neoplasm.

What interventions are being tested in trial NCT06895473?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Lumbar Puncture (PROCEDURE), Cytarabine (DRUG), Methotrexate (DRUG), Therapeutic Hydrocortisone (DRUG).

Who is sponsoring clinical trial NCT06895473?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06895473 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.