At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
Axicabtagene Ciloleucel +3 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 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)
In Brief
A Phase 2 clinical trial evaluating Axicabtagene Ciloleucel, Rituximab, and 2 other interventions for Refractory Large B-cell Lymphoma. Completed, enrolled 27 participants across 14 sites.
Detailed Summary
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Large B-cell Lymphoma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartNov 2019
Primary CompletionJan 2023
TodayJul 2026
First PostedJun 28, 2019
Enrollment StartNov 5, 2019
Primary CompletionJan 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.0 years ago
Interventions
Axicabtagene Ciloleucelbiological
A single infusion of CAR-transduced autologous T cells administered intravenously
Rituximabdrug
Administered intravenously
Fludarabinedrug
Administered according to package insert
Cyclophosphamidedrug
Administered according to package insert