NCT04002401

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (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 combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Detailed description

Following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (Study KT-US-982-5968). Participants will complete the remainder of the 15-year follow-up assessments in the KT-US-982-5968 study.

Conditions

• Refractory Large B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene Ciloleucel	A single infusion of CAR-transduced autologous T cells administered intravenously
DRUG	Rituximab	Administered intravenously
DRUG	Fludarabine	Administered according to package insert
DRUG	Cyclophosphamide	Administered according to package insert

Timeline

• Start date: 2019-11-05
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2019-06-28
• Last updated: 2024-02-20
• Results posted: 2024-02-20

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study