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Lazarus: IT Therapy for ICANS

NCT07763210 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-08-14

No results posted yet for this study

Summary

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.

Researchers will compare Axi-cel to Brexu-cel see if there will be a reduction in ICANS when compared to historical experience.

Conditions

Interventions

DRUG

Hydrocortisone

100 mg IT with onset of grade 1/2 ICANS

DRUG

Cytarabine 100 MG/ML

100 mg IT with onset of grade 1/2 ICANS

DRUG

Dexamethasone

IV 10mg

DRUG

Methylprednisolone

1g daily until adverse events resolves

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Bhagirathbhai Dholaria · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-10-01
Completion
2030-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763210 on ClinicalTrials.gov