NCT05605899

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.

Detailed description

Five years after randomization, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Conditions

• High-risk Large B-cell Lymphoma (LBCL)

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene Ciloleucel	A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously
DRUG	Etoposide	Administered intravenously
DRUG	Rituximab	Administered intravenously
DRUG	Doxorubicin	Administered intravenously
DRUG	Vincristine	Administered intravenously
DRUG	Prednisone	Administered orally

Timeline

• Start date: 2023-02-10
• Primary completion: 2031-03-01
• Completion: 2031-03-01
• First posted: 2022-11-04
• Last updated: 2026-04-15

Locations

85 sites across 12 countries: United States, Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study