IT Therapy for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Bhagirathbhai Dholaria
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with lymphoma, specifically cutaneous T-cell non-Hodgkin lymphoma, who have had their cancer come back. Participants must be receiving a treatment called axi-cel and are being monitored for nervous system side effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy and CAR T Cell Administration
Participants receive standard fludarabine and cyclophosphamide-based LD chemotherapy followed by CAR T infusion
CAR T Infusion
Patients receive brexu-cel IV on day 0
Post CAR T Phase
Patients without progressive disease receive nemtabrutinib PO QD on days 1-28 of each cycle, repeating every 28 days for up to 24 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cytarabine
- Dexamethasone
- Hydrocortisone
- Methylprednisolone
Trial Overview
The study tests if giving certain medicines (cytarabine, hydrocortisone, dexamethasone, methylprednisolone) directly into the spinal fluid can reduce or shorten serious brain-related side effects (ICANS) in patients treated with axi-cel compared to past results.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Drugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel
Drugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
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