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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
NCT02625480 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02625480
The ClinicalTrials.gov registry entry for NCT02625480 describes a study currently listed as active not recruiting. 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 95 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 2 conditions, with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 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: NCT02625480 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, 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 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-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02625480?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Brexucabtagene Autoleucel (KTE-X19) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02625480?
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 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.
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