Lazarus: IT Therapy for ICANS
ConditionNon-hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center
About 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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Diffuse large B-cell lymphoma (DLBCL)
Primary mediastinal large B-cell lymphoma (PMBCL)
Transformed follicular lymphoma (tFL)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Hydrocortisone
- Cytarabine 100 MG/ML
- Dexamethasone
- Methylprednisolone
Treatment groups
59 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt-Ingram Cancer Center
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov