Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Elliot Stieglitz (ucsf)
Headshot of Elliot Stieglitz
Elliot Stieglitz

Description

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).

Official Title

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Details

All participants who received KTE-X19, and have completed at least 24 months of protocol assessments, will be transitioned to a separate long-term follow-up (LTFU) study. The purpose of the LTFU study (KT-US-982-5968.) is to complete the remainder of the 15-year follow-up assessments.

Keywords

Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, Lymphoma, Leukemia, Non-Hodgkin Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, B-Cell Lymphoma, Cyclophosphamide, Fludarabine, Brexucabtagene autoleucel, Brexucabtagene Autoleucel (KTE-X19)

Eligibility

Locations

  • UCSF Benioff Children's Hospital
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Elliot Stieglitz (ucsf)
    Juvenile myelomonocytic leukemia (JMML) is a blood cancer that affects young children and is difficult to diagnose. Currently available therapies cure only half of patients, with some children experiencing an aggressive disease course while some children get better with very little treatment. We have now shown that the presence of secondary mutations at diagnosis predicts a poor outcome.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT02625480
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 95 people participating
Last Updated