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
Completed · Phase 1/Phase 2
Conditions studied: Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
In brief
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).
Key facts
- Study ID
- NCT02625480
- Run by
- Kite, A Gilead Company
- People needed
- 95
- Starts
- 2016-02-01
- Expected to finish
- 2026-03-25
- Last updated by the study team
- 2026-04-09
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- UCSF Benioff Children's Hospital — San Francisco, California, United States
- University of Miami Hospital & Clinics — Miami, Florida, United States
- Kapi'olani Medical Center for Women and Children — Honolulu, Hawaii, United States
- Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
- Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Monroe-Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
- Texas Children's Hospital — Houston, Texas, United States
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- University of Virginia Health System, Pediatric Hematology/Oncology Clinic — Charlottesville, Virginia, United States
- University Hospital Gent — Ghent, Belgium
- The Hospital for Sick Children — Toronto, Canada
- University Hospital Brno — Brno, Czechia
- Unité d'Oncologie et Hématologie Pédiatriques — Bordeaux, France
- Institut d'Hematologie et Oncologie Pediatrique — Lyon, France
- Hopital d'Enfants la Timone — Marseille, France
- Hopital Robert Debre - Sevice d'Hemato-immunologic — Paris, France
- University Medical Center Hamburg-Eppendorf (UKE) — Hamburg, Germany
- Bambino Gesù Children's Hospital — Rome, Italy
- Prinses Maxima Centrum — Utrecht, Netherlands
Full record on ClinicalTrials.gov
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