A Phase 2 Trial of Early Enhanced Interventions to Prevent ICANS After CD19 CAR T Therapy in Patients With Non-Hodgkin Lymphoma: Lazarus Trial
Vanderbilt-Ingram Cancer Center
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.
Description
PRIMARY OBJECTIVE: I. Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience. OUTLINE: This is an open label, phase 2 study of early intervention using IT cytarabine 100mg and IT hydrocortisone 100mg to treat ICANS after brexu-cel and axi-cel in NHL. Participants will be screened within 30 days prior to start of lymphodepletion chemotherapy. Lymphodepleting Chemotherapy and CAR T Cell Administration Period- Participants will receive standard fludarabine and cyclophosphamide-based LD chemotherapy starting day-5 followed…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically confirmed non-Hodgkin Lymphoma, including the following types defined by the World Health Organization (2017) or International Consensus Classification (2022): * Diffuse large B-cell lymphoma (DLBCL) * Primary mediastinal large B-cell lymphoma (PMBCL) * Transformed follicular lymphoma (tFL) * Transformed marginal zone lymphoma (tMZL) * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements * Follicular lymphoma * Mantle cell lymphoma * Marginal zone lymphoma 3. Meets institutional eligibil…
Interventions
- DrugHydrocortisone
100 mg IT with onset of grade 1/2 ICANS
- DrugCytarabine 100 MG/ML
100 mg IT with onset of grade 1/2 ICANS
- DrugDexamethasone
IV 10mg
- DrugMethylprednisolone
1g daily until adverse events resolves
Location
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee