Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
Completed · Phase 1/Phase 2
Conditions studied: Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma (TFL), Primary Mediastinal B-cell Lymphoma (PMBCL), High Grade B-cell Lymphoma (HGBCL)
In brief
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.
Key facts
- Study ID
- NCT02348216
- Run by
- Kite, A Gilead Company
- People needed
- 307
- Starts
- 2015-04-21
- Expected to finish
- 2023-07-27
- Last updated by the study team
- 2024-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Nebraska — Omaha, Nebraska, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- University of Rochester — Rochester, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio, United States
- Sarah Cannon - Tennesee — Nashville, Tennessee, United States
- Vanderbilt University — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Sarah Cannon-Methodist Healthcare System - San Antonio — San Antonio, Texas, United States
- Vancouver General Hospital — Vancouver, British Columbia, Canada
- Princess Margaret — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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