A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL) (ZUMA-1)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/ Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: I/II
Principal Investigator: Vose, Julie
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02348216#eligibility
Summary
This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, and Cohort 5).
The primary objectives of this study are:
Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions and tumor debulking therapy on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicity