Trials / Completed
CompletedNCT02625480
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
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Kite, A Gilead Company · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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.
Conditions
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
- Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Brexucabtagene Autoleucel (KTE-X19) | |
| DRUG | Fludarabine | Administered intravenously |
| DRUG | Cyclophosphamide | Administered intravenously |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2026-03-25
- Completion
- 2026-03-25
- First posted
- 2015-12-09
- Last updated
- 2026-04-09
Locations
30 sites across 11 countries: United States, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02625480. Inclusion in this directory is not an endorsement.