CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Axicabtagene Ciloleucel +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.

Search/NCT03761056
NCT03761056Phase 2Completed
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A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)

Kite, A Gilead Company·interventional·Posted Dec 3, 2018·Updated Dec 4, 2024

In Brief

A Phase 2 clinical trial evaluating Axicabtagene Ciloleucel, Fludarabine, and 1 other intervention for B-cell Lymphoma. Completed, enrolled 42 participants across 7 sites in 3 countries.

Detailed Summary

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Lymphoma
CountriesAustralia, France, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 3, 2018
Enrollment StartJan 29, 2019
Primary CompletionOct 12, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.6 years ago

Interventions

Axicabtagene Ciloleucelbiological

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Fludarabinedrug

Administered according to package insert

Cyclophosphamidedrug

Administered according to package insert