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Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Vanderbilt-Ingram Cancer Center

Record History

  1. Notable Primary endpoint(s) modified Recruitment opened · Primary completion moved earlier from Oct 1, 2029 to Mar 1, 2028 · Completion moved earlier from Oct 1, 2030 to Oct 1, 2029 · 7 more Show 10 more changesShow less
    • Recruitment opened
    • Primary completion moved earlier from Oct 1, 2029 to Mar 1, 2028
    • Completion moved earlier from Oct 1, 2030 to Oct 1, 2029
    • Interventions modified
    • Start date changed from estimate of Oct 1, 2026 to Sep 25, 2026
    • Eligibility criteria expanded, about 55 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Study description shortened, about 97 words
    • Site details revised
    • Study title expanded, about 15 words
  2. Minor 2 versions Re-verified since Aug 12, 2026, no change to tracked fieldsv2-v3
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07763210
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Gilead Sciences
Conditions Non-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Marginal Zone Lymphoma
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov