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A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
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, Cohort 5 and Cohort 6). 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 on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
University of California San Diego (UCSD)
La Jolla, California, United States
Stanford University
Palo Alto, California, United States
University of California Los Angeles (UCLA)
Santa Monica, California, United States
Sarah Cannon - Denver
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Start Date
April 21, 2015
Primary Completion Date
July 27, 2023
Completion Date
July 27, 2023
Last Updated
June 4, 2024
307
ACTUAL participants
Axicabtagene Ciloleucel
BIOLOGICAL
Fludarabine
DRUG
Cyclophosphamide
DRUG
Levetiracetam
DRUG
Tocilizumab
DRUG
Dexamethasone
DRUG
High-dose methylprednisolone
DRUG
Bendamustine
DRUG
Rituximab
DRUG
Doxorubicin
DRUG
Prednisone
DRUG
Vincristine
DRUG
Ifosfamide
DRUG
Carboplatin
DRUG
Etoposide
DRUG
Gemcitabine
DRUG
Oxaliplatin
DRUG
Cisplatin
DRUG
Methylprednisolone
DRUG
Lead Sponsor
Kite, A Gilead Company
NCT04792489
NCT02570542
Data Source & Attribution
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