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

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).

Timeline

Start

2016-02-01

Primary completion

2026-03-25

Completion

2026-03-25

Publications

• Wayne AS, Huynh V, Hijiya N, Rouce RH, Brown PA, Krueger J, Kitko CL, Ziga ED, Hermiston ML, Richards MK, Baruchel A, Schuberth PC, Rossi J, Zhou L, Goyal L, Jain R, Vezan R, Masouleh BK, Lee DW. Three-year results from phase I of ZUMA-4: KTE-X19 in pediatric relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2023 Mar 1;108(3):747-760. doi: 10.3324/haematol.2022.280678.

Drugs

Indications