At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 125 enrolled
Drug / intervention
brexucabtagene autoleucel +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)
In Brief
A Phase 2 clinical trial evaluating brexucabtagene autoleucel, Cyclophosphamide, and 1 other intervention for Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia. Completed, enrolled 125 participants across 33 sites in 5 countries.
Detailed Summary
The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Netherlands, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartMar 2016
Primary CompletionJul 2022
Study CompletionNov 2023
TodayJul 2026
First PostedNov 25, 2015
Enrollment StartMar 7, 2016
Primary CompletionJul 23, 2022
Study CompletionNov 3, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 10.6 years ago
Interventions
brexucabtagene autoleucelbiological
A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.
Cyclophosphamidedrug
Administered intravenously.
Fludarabinedrug
Administered intravenously.