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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: Recruiting Phase 2 study of Hematopoietic and Lymphatic System Neoplasm, sponsored by OHSU Knight Cancer Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be reported using the efficacy set. Point estimate, along with exact two-sided 95% confidence interval will be reported.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2025-06-04 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06895473 shows while recruiting
NCT06895473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 483-participant average among 62 other Hematopoietic and Lymphatic System Neoplasm trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06895473's enrollment target sits among peer trials
26 58th of 62 higher than 5 of 62 other Hematopoietic and Lymphatic System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphatic System Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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