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NCT02625480 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, sponsored by Kite, A Gilead Company.
- Active
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT02625480: Active Phase 1 study of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, sponsored by Kite, A Gilead Company.
NCT02625480 is a Phase 1 study of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Kite, A Gilead Company. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02625480, a Phase 1 study of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Kite, A Gilead Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).
Primary Outcome
Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel (KTE-X19)-related events with onset within the first 28 days following brexucabtagene autoleucel (KTE-X19) infusion.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Brexucabtagene Autoleucel (KTE-X19)
Study Locations (20)
Other
- University Hospital Gent - Ghent
- The Hospital for Sick Children - Toronto
- University Hospital Brno - Brno
- Unité d'Oncologie et Hématologie Pédiatriques - Bordeaux
- Institut d'Hematologie et Oncologie Pediatrique - Lyon
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital of Orange County - Orange
- UCSF Benioff Children's Hospital - San Francisco
New York
- Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP - New York
- University of Rochester Medical Center - Rochester
Texas
- Texas Children's Hospital - Houston
- The University of Texas M.D. Anderson Cancer Center - Houston
Florida
- University of Miami Hospital & Clinics - Miami
Hawaii
- Kapi'olani Medical Center for Women and Children - Honolulu
Illinois
- Ann & Robert H. Lurie Children's Hospital - Chicago
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
What the registry record for NCT02625480 still lists
NCT02625480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 2 conditions, with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02625480 names 20 study sites across 12 states, led by Other, California, New York.
Frequently Asked Questions
What is clinical trial NCT02625480 about?
NCT02625480 is a clinical study titled "Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma". The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL)...
What is the current status of trial NCT02625480?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2016-02-01. Estimated completion is 2026-02.
What conditions does trial NCT02625480 study?
This clinical trial studies the following conditions: Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT02625480?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Brexucabtagene Autoleucel (KTE-X19) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02625480?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02625480 being conducted?
This trial has 20 study locations across California, Florida, Hawaii, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02625480's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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