At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 enrolled
Drug / intervention
Fludarabine +2 moredrug
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 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 1 other intervention for Relapsed/Refractory Mantle Cell Lymphoma. Completed, enrolled 95 participants across 40 sites in 6 countries.
Detailed Summary
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory Mantle Cell Lymphoma
CountriesFrance, Germany, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedMay 2021
Primary CompletionJun 2025
TodayJul 2026
First PostedMay 10, 2021
Enrollment StartApr 27, 2021
Primary CompletionJun 17, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.1 years ago
Interventions
Fludarabinedrug
Administered intravenously
Cyclophosphamidedrug
Administered intravenously
Brexucabtagene autoleucelbiological
A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells