Lazarus: IT Therapy for ICANS (NCT07763210) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lazarus: IT Therapy for ICANS
United States59 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Histologically confirmed non-Hodgkin Lymphoma, including the following types defined by the World Health Organization (2017) or International Consensus Classification (2022):
. Meets institutional eligibility criteria to receive standard of care CD19 CAR T therapy.
. The participant (or legally acceptable representative if applicable) has provided documented informed consent for the trial.
. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to allocation.
. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience
Timeframe: From first IT therapy through 14 days from last IT therapy
. Participants with HIV are eligible if they meet ALL of the following criteria:
. Adequate organ function as defined in the following table. Specimens must be collected within 30 days of LD chemo.
Exclusion criteria
. Active HBV/HCV infection. See Inclusion Criteria 7 (HBV) and 8 (HCV) for requirements.
. Patients with uncontrolled systemic infection despite appropriate antibiotics or other treatment.
. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
. History of platelet transfusion refractoriness or participant declining transfusion support (i.e. Jehovah's witness).
. Participant requiring anti-platelets (aspirin, clopidogrel, ticagrelor) or systemic anticoagulants (coumadin, DOACs) which cannot be safely held at start of LD chemotherapy through Day+28. This is required to avoid delays in rapidly getting IT therapy.
. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than high-grade B cell lymphoma. The only exceptions allowed are:
. With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance
. With a Gleason score of 3+4 that has been treated \>6 months prior to full study screening and considered to have a very low risk of recurrence; or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.