Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
Public ClinicalTrials.gov record NCT02348216. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02348216
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 307 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 21, 2015 (Actual)
- Primary completion
- Jul 27, 2023 (Actual)
- Completion
- Jul 27, 2023 (Actual)
- Last update posted
- Jun 4, 2024
2015 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| City of Hope | Duarte | California | 91010-3012 | — |
| University of California San Diego (UCSD) | La Jolla | California | 92093-0820 | — |
| Stanford University | Palo Alto | California | 94305 | — |
| University of California Los Angeles (UCLA) | Santa Monica | California | 90404 | — |
| Sarah Cannon - Denver | Denver | Colorado | 80218 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska | Omaha | Nebraska | 68198-7680 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | 44195 | — |
| Sarah Cannon - Tennesee | Nashville | Tennessee | 37203 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030-4000 | — |
| Sarah Cannon-Methodist Healthcare System - San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02348216, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02348216 live on ClinicalTrials.gov.