NCT03391466

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 359 (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 assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Detailed description

After completing the treatment period, all participants will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, participants who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968 (NCT05041309).

Conditions

• Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
BIOLOGICAL	Axicabtagene Ciloleucel	Administered intravenously
DRUG	Platinum-containing Salvage Chemotherapy	Platinum-containing salvage chemotherapy (Rituximab-ifosfamide, carboplatin, etoposide (R-ICE), Rituximab-dexamethasone, cytarabine, cisplatin,oxaliplatin (R-DHAP), Rituximab-etoposide, methylprednisolone, cisplatin, cytarabine (R-ESHAP), or Rituximab-gemcitabine, dexamethasone, cisplatin/carboplatin (R-GDP) as selected by treating investigator).
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously

Timeline

• Start date: 2018-01-25
• Primary completion: 2021-03-18
• Completion: 2024-11-25
• First posted: 2018-01-05
• Last updated: 2025-12-01
• Results posted: 2024-03-07

Locations

72 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study