Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma
Public ClinicalTrials.gov record NCT07763210. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Trial of Early Enhanced Interventions to Prevent ICANS After CD19 CAR T Therapy in Patients With Non-Hodgkin Lymphoma: Lazarus Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to reduce the duration of ICANS and incidence of G3 or great ICANS in participants who receive axi-cel. The main questions the study aims to answer are: Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience. This phase II trial tests how well giving intrathecal (IT) cytarabine and hydrocortisone works for the early treatment of immune effector cell associated neurotoxicity syndrome (ICANS) in patients undergoing chimeric antigen response (CAR) t cell therapy for the treatment of non Hodgkin Lymphoma that has come back after a period of improvement (recurrent) or that has not responded o previous treatment (refractory). CAR T-cell therapy can sometimes cause an overactive immune response and inflammation. This can cause a side effect called ICANS that affects the rain and may lead to symptoms such as confusion, difficulty speaking, or other neurological problems. Giving cytarabine and hydrocortisone directly into the fluid around the brain and spinal cord (called intrathecal treatment) may help lower the body's immune response and reduce inflammation. Giving IT cytarabine and hydrocortisone may be effective for early treatment of CANS in patients undergoing CAR T cell therapy for relapsed or refractory non Hodgkin Lymphoma.
Study identification
- NCT ID
- NCT07763210
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 59 participants
Conditions and interventions
Conditions
Interventions
- Therapeutic Hydrocortisone Drug
- Cytarabine Drug
- Dexamethasone Drug
- Methylprednisolone Drug
- Cyclophosphamide Drug
- Axicabtagene Ciloleucel Biological
- Brexucabtagene Autoleucel Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2026 (Actual)
- Primary completion
- Mar 1, 2028 (Estimated)
- Completion
- Oct 1, 2029 (Estimated)
- Last update posted
- Oct 2, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37203 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07763210, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07763210 live on ClinicalTrials.gov.