NCT05459571

Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma

A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.

Detailed description

Participants who complete at minimum 24 months follow up will be transitioned 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 or Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene Ciloleucel	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously
DRUG	Dexamethasone	Administered orally or intravenously

Timeline

• Start date: 2022-08-09
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2022-07-15
• Last updated: 2026-02-02

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study