Lazarus: IT Therapy for ICANS

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT07763210
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydrocortisone — DRUG
    100 mg IT with onset of grade 1/2 ICANS
  • Cytarabine 100 MG/ML — DRUG
    100 mg IT with onset of grade 1/2 ICANS
  • Dexamethasone — DRUG
    IV 10mg
  • Methylprednisolone — DRUG
    1g daily until adverse events resolves

Study Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 1, 2029
Completion
Oct 1, 2030

Study Design

Enrollment
59 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hydrocortisone + Cytarabine + Dexamethasone or Methylprednisolone
    Drugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel
  • Active Comparator: Prophylactic corticosteroids with Dexamethasone
    Drugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel

Primary Outcome Measure

Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience [ Time Frame: From first IT therapy through 14 days from last IT therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37203
Vanderbilt-Ingram Service Services for Timely Access
[email protected]
800-811-8480
Bhagirathbhai Dholaria (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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