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
Kite Study Director Study Director Kite, A Gilead Company
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Studienlocations (3 von 37)
University Medical Center Hamburg-Eppendorf (UKE) 20246 Hamburg (Hamburg) GermanyRekrutierend» Google-MapsKlinikum Innenstadt der LMU 80337 Munich (Bayern) GermanyZurückgezogen» Google-MapsCity of Hope 91010 Duarte United StatesZurückgezogen» Google-Maps
Children's Hospital Los Angeles 90027 Los Angeles United StatesRekrutierend» Google-MapsChildren's Hospital of Orange County 92868 Orange United StatesRekrutierend» Google-MapsUCSF Benioff Children's Hospital 94158 San Francisco United StatesRekrutierend» Google-MapsChildren's Hospital Colorado 80045 Aurora United StatesZurückgezogen» Google-MapsUniversity of Miami Hospital & Clinics 33136 Miami United StatesRekrutierend» Google-MapsKapi'olani Medical Center for Women and Children 96826 Honolulu United StatesRekrutierend» Google-MapsAnn & Robert H. Lurie Children's Hospital 60611 Chicago United StatesRekrutierend» Google-MapsUniversity of Chicago 60637 Chicago United StatesZurückgezogen» Google-MapsJohns Hopkins University 21287 Baltimore United StatesAktiv, nicht rekrutierend» Google-MapsChildren's Hospitals and Clinics of Minnesota 55404 Minneapolis United StatesAbgeschlossen» Google-MapsMayo Clinic 55902 Rochester United StatesZurückgezogen» Google-MapsColumbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP 10032 New York United StatesRekrutierend» Google-MapsUniversity of Rochester Medical Center 14642 Rochester United StatesRekrutierend» Google-MapsCincinnati Children's Hospital Medical Center 45229 Cincinnati United StatesZurückgezogen» Google-MapsThe Children's Hospital of Philadelphia 19104 Philadelphia United StatesRekrutierend» Google-MapsMonroe-Carell Jr. Children's Hospital at Vanderbilt 37232 Nashville United StatesRekrutierend» Google-MapsTexas Children's Hospital 77030 Houston United StatesRekrutierend» Google-MapsThe University of Texas M.D. Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsUniversity of Virginia Health System, Pediatric Hematology/Oncology Clinic 22908 Charlottesville United StatesRekrutierend» Google-MapsMedical College of Wisconsin (Administrative Offices) 53226 Milwaukee United StatesZurückgezogen» Google-MapsUniversity Hospital Gent 9000 Gent BelgiumRekrutierend» Google-MapsThe Hospital for Sick Children M5G 1X8 Toronto CanadaRekrutierend» Google-MapsUniversity Hospital Brno 625 00 Brno CzechiaRekrutierend» Google-MapsUnité d'Oncologie et Hématologie Pédiatriques 33 000 Bordeaux FranceRekrutierend» Google-MapsInstitut d'Hematologie et Oncologie Pediatrique 69373 Lyon FranceAbgeschlossen» Google-MapsHopital d'Enfants la Timone 13385 Marseille Cedex 5 FranceRekrutierend» Google-MapsHopital Robert Debre - Sevice d'Hemato-immunologic 75935 Paris Cedex 19 FranceRekrutierend» Google-MapsBambino Gesù Children's Hospital 00165 Rome ItalyRekrutierend» Google-MapsPrinses Maxima Centrum 3508 Utrecht NetherlandsRekrutierend» Google-MapsJurasz University Hospital 1; Collegium Medicum 85-094 Bydgoszcz PolandRekrutierend» Google-MapsWroclaw Medical University 50-556 Wroclaw PolandRekrutierend» Google-MapsHospital Sant Joan de Déu 08950 Barcelona SpainRekrutierend» Google-MapsHospital Universitario La Paz 28046 Madrid SpainRekrutierend» Google-MapsKarolinska University Hospital SE-141 86 Stockholm SwedenRekrutierend» Google-Maps
1. Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT) (Time Frame - Up to 28 days): 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.
2. Phase 2: Overall Complete Remission Rate in the ALL Cohort (Time Frame - Up to 24 months): Overall complete remission rate will be determined per independent review.
3. Phase 2: Objective Response Rate in the NHL Cohorts (Time Frame - Up to 24 months): Objective Response Rate will be determined per investigator review.
Secondary outcome:
1. Minimum Residual Disease Negative Remission Rate in the ALL Cohort (Time Frame - Up to 3 months): Minimal residual disease (MRD) response rate is defined as MRD < 10^-4 per the standard assessment.
2. Allogeneic Stem Cell Transplant Rate in the ALL Cohort (Time Frame - Up to 24 months): The incidence of allogeneic stem cell transplant will be analyzed.
3. Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts (Time Frame - Up to 15 years): The PRO scores will be measured by the Pediatric Quality of Life Inventory (PedsQL) for children and adolescents and European Quality-of-Life-5 Dimension (EQ-5D) for all participants.
The PedsQL comprises of 23 items in the dimensions of physical, emotional, social, and school functioning. Transformed total, physical health summary, and psychosocial health summary scores range from 0-100 with higher scores indicating better health-related quality of life.
The EQ-5D is a generic questionnaire for assessing the participant's overall health status. The EQ-5D consists of a 5 dimension descriptive system including mobility, self-care, usual activities, pain/comfort, and anxiety/depression and a visual analogue scale (EQ-VAS) which allows the respondent to record health. The VAS allows a participant to indicate self-reported health on a vertical scale, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The PedsQL scores and EQ-5D scores will be reported.
4. Overall Complete Remission Rate in the ALL Cohort (Time Frame - Up to 15 years)
5. Relapse-Free Survival for the ALL Cohort (Time Frame - Up to 24 months): Relapse-Free Survival is defined as the time from the brexucabtagene autoleucel (KTE-X19) infusion date to the date of disease relapse or death from any cause.
6. Progression Free Survival in the NHL Cohort (Time Frame - Up to 15 years)
7. Overall Survival in the ALL and NHL Cohorts (Time Frame - Up to 15 years): Overall survival is defined as the time from brexucabtagene autoleucel (KTE-X19) infusion to the date of death from any cause.
8. Duration of Remission in the ALL and NHL Cohorts (Time Frame - Up to 24 months): Duration of remission is defined as the time between the participant's first complete response per independent review to relapse or any death in the absence of documented relapse.
9. Percentage of Participants with Anti-Brexucabtagene Autoleucel (KTE-X19) Antibodies in Blood in the ALL and NHL Cohorts (Time Frame - Up to 15 years)
10. Percentage of Participants Experiencing Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values in ALL and NHL Cohorts (Time Frame - Up to 15 years)
11. CR Rate Within 3 Months Per Independent Review in ALL Cohorts (Time Frame - Up to 15 years)