NCT05371093

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Detailed description

Five years after the last study participant is randomized, 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

• Relapsed/Refractory Follicular Lymphoma

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	Lenalidomide	Administered orally
DRUG	Rituximab	Administered intravenously
DRUG	Doxorubicin	Administered intravenously
DRUG	Vincristine	Administered intravenously
DRUG	Prednisone	Administered orally
DRUG	Bendamustine	Administered intravenously

Timeline

• Start date: 2022-09-22
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2022-05-12
• Last updated: 2025-10-15

Locations

52 sites across 7 countries: United States, France, Germany, Italy, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study