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NCT02348216 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
A Phase 1 study of Relapsed Diffuse Large B-cell Lymphoma and High Grade B-cell Lymphoma (HGBCL), sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 307
- Enrollment target
- 20
- Study locations
NCT02348216: Completed Phase 1 study of Relapsed Diffuse Large B-cell Lymphoma and High Grade B-cell Lymphoma (HGBCL), sponsored by Kite, A Gilead Company.
NCT02348216 is a Phase 1 study of Relapsed Diffuse Large B-cell Lymphoma and High Grade B-cell Lymphoma (HGBCL) that has completed, run by Kite, A Gilead Company. The registered enrollment target is 307 participants, above the 174-participant average among 5 other Relapsed Diffuse Large B-cell Lymphoma trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348216, a Phase 1 study of Relapsed Diffuse Large B-cell Lymphoma and High Grade B-cell Lymphoma (HGBCL), has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 307 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DLT was defined as axicabtagene ciloleucel-related events with onset within first 30 days following infusion: * Grade (GR) 4 neutropenia lasting \> 21 days and GR 4 thrombocytopenia lasting \> 35 days from day of cell transfer; * Any axicabtagene ciloleucel-related AE requiring intubation; * All other GR 3 toxicities lasting \> 3 days and all GR 4 toxicities, with exception of following conditions which were not considered DLTs: aphasia/dysphasia or confusion/cognitive disturbance which resolve
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 |
What the finished NCT02348216 record still lists
NCT02348216 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 5 other Relapsed Diffuse Large B-cell Lymphoma trials with a reported enrollment target (76% higher).
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.
NCT02348216 names 20 study sites across 15 states, led by California, Florida, New York.
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, High Grade B-cell Lymphoma (HGBCL), Transformed Follicular Lymphoma (tFL), Refractory Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL).
What interventions are being tested in trial NCT02348216?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Levetiracetam (DRUG), Tocilizumab (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT02348216?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
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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