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Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
NCT02348216 · View on ClinicalTrials.gov ↗
Study 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, 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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Levetiracetam
- DRUG Tocilizumab
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (20)
California
- City of Hope — Duarte
- University of California San Diego (UCSD) — La Jolla
- Stanford University — Palo Alto
- University of California Los Angeles (UCLA) — Santa Monica
Florida
- University of Miami — Miami
- Moffitt Cancer Center — Tampa
New York
- University of Rochester — Rochester
- Montefiore Medical Center — The Bronx
Arizona
- Banner MD Anderson Cancer Center — Gilbert
Colorado
- Sarah Cannon - Denver — Denver
Illinois
- Loyola University Medical Center — Maywood
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Massachusetts
- Dana Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2015-04-21 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02348216
The ClinicalTrials.gov registry entry for NCT02348216 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kite, A Gilead Company, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Relapsed Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02348216 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02348216 about?
NCT02348216 is a clinical study titled "Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants 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 ...
What is the current status of trial NCT02348216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 307 participants. The study started on 2015-04-21. Estimated completion is 2023-07-27.
What conditions does trial NCT02348216 study?
This clinical trial studies the following conditions: Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B Cell Lymphoma (DLBCL), High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02348216?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Levetiracetam (DRUG), Tocilizumab (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02348216?
This trial is sponsored by Kite, A Gilead Company, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02348216 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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