Study on Using Intrathecal Cytarabine and Hydrocortisone for Early Treatment of Brain Side Effects in CAR T Therapy for Non-Hodgkin Lymphoma

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07763210

Provider View

This clinical trial is testing whether giving cytarabine and hydrocortisone directly into the fluid around the brain and spinal cord can help reduce brain-related side effects in patients receiving CAR T-cell therapy for Non-Hodgkin Lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to see if giving cytarabine and hydrocortisone directly into the fluid around the brain and spinal cord can help reduce the severity and duration of a side effect called ICANS, which affects the brain in patients undergoing CAR T-cell therapy for Non-Hodgkin Lymphoma. ICANS can cause symptoms like confusion and difficulty speaking. This study aims to find out if this treatment can help manage these symptoms early on in patients whose cancer has come back or not responded to previous treatments.

Description

The main goal of this study is to see if intrathecal (IT) therapy with cytarabine and hydrocortisone can reduce severe brain-related side effects (ICANS) in patients receiving CAR T-cell therapy for Non-Hodgkin Lymphoma. The study will also look at how this treatment affects other side effects, its safety, and its impact on patients' quality of life.

Patients will receive standard chemotherapy before CAR T-cell therapy. If they develop mild to moderate ICANS, they will receive IT cytarabine and hydrocortisone along with standard treatments. If symptoms persist or worsen, additional IT treatments may be given. The study will monitor patients for disease progression or unacceptable side effects, with a maximum of two IT treatments allowed. Additional standard treatments may be given if no improvement is seen within specified timeframes. Patients will undergo lumbar punctures for fluid collection and regular blood tests throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older.
  • Diagnosed with specific types of Non-Hodgkin Lymphoma, such as Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.
  • Eligible for standard CD19 CAR T-cell therapy.
  • Provided informed consent to participate.
  • If positive for hepatitis B, must have undetectable viral load after at least 4 weeks of antiviral therapy.
  • If with a history of hepatitis C, must have undetectable viral load after completing antiviral therapy.
  • If HIV positive, must have a CD4 count of at least 350, undetectable viral load, and be on stable ART regimen.
  • Adequate organ function based on specific blood test results.
  • Men must agree to use contraception or abstain from intercourse during and after treatment.
  • Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.

Exclusion Criteria

  • Active hepatitis B or C infection.
  • Uncontrolled systemic infection.
  • Conditions or treatments that might interfere with study results or participation.
  • History of platelet transfusion refractoriness or refusal of transfusion support.
  • Need for certain blood thinners that cannot be stopped.
  • Active cancers other than high-grade B-cell lymphoma, with some exceptions.
  • Positive pregnancy test for women of childbearing potential.
  • Primary CNS lymphoma or certain other conditions affecting the brain.
  • Recent live vaccine administration.
  • Participation in another clinical trial that may affect CAR T therapy.
  • Immunodeficiency or use of high-dose steroids or immunosuppressive therapy.
  • Active autoimmune disease requiring certain treatments.
  • Not fully recovered from major surgery.

Locations

FACILITYZIPCITYSTATE
Vanderbilt University/Ingram Cancer Center37203NashvilleTennessee

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.