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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

February 1, 2016

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaRelapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Interventions
BIOLOGICAL

Brexucabtagene Autoleucel (KTE-X19)

DRUG

Fludarabine

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously

Trial Locations (30)

3508

Prinses Maxima Centrum, Utrecht

9000

University Hospital Gent, Ghent

10032

Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP, New York

13385

Hopital d'Enfants la Timone, Marseille

14642

University of Rochester Medical Center, Rochester

19104

The Children's Hospital of Philadelphia, Philadelphia

20246

University Medical Center Hamburg-Eppendorf (UKE), Hamburg

21287

Johns Hopkins University, Baltimore

22908

University of Virginia Health System, Pediatric Hematology/Oncology Clinic, Charlottesville

28046

Hospital Universitario La Paz, Madrid

33136

University of Miami Hospital & Clinics, Miami

37232

Monroe-Carell Jr. Children's Hospital at Vanderbilt, Nashville

55404

Children's Hospitals and Clinics of Minnesota, Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital, Chicago

69373

Institut d'Hematologie et Oncologie Pediatrique, Lyon

75935

Hopital Robert Debre - Sevice d'Hemato-immunologic, Paris

77030

Texas Children's Hospital, Houston

The University of Texas M.D. Anderson Cancer Center, Houston

90027

Children's Hospital Los Angeles, Los Angeles

92868

Children's Hospital of Orange County, Orange

94158

UCSF Benioff Children's Hospital, San Francisco

96826

Kapi'olani Medical Center for Women and Children, Honolulu

M5G 1X8

The Hospital for Sick Children, Toronto

625 00

University Hospital Brno, Brno

33 000

Unité d'Oncologie et Hématologie Pédiatriques, Bordeaux

00165

Bambino Gesù Children's Hospital, Rome

85-094

Jurasz University Hospital 1; Collegium Medicum, Bydgoszcz

50-556

Wroclaw Medical University, Wroclaw

08950

Hospital Sant Joan de Déu, Barcelona

SE-141 86

Karolinska University Hospital, Stockholm

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY

NCT02625480 - 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 | Biotech Hunter | Biotech Hunter