Trials / Completed
CompletedNCT03761056
Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Kite, A Gilead Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Axicabtagene Ciloleucel | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells |
| DRUG | Fludarabine | Administered according to package insert |
| DRUG | Cyclophosphamide | Administered according to package insert |
Timeline
- Start date
- 2019-01-29
- Primary completion
- 2023-10-12
- Completion
- 2023-10-12
- First posted
- 2018-12-03
- Last updated
- 2024-12-04
- Results posted
- 2022-07-08
Locations
7 sites across 3 countries: United States, Australia, France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03761056. Inclusion in this directory is not an endorsement.