NCT03105336

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.

Detailed description

After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma
• Indolent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene ciloleucel	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously

Timeline

• Start date: 2017-06-06
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2017-04-07
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

19 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study