CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 359 enrolled
Drug / intervention
Axicabtagene Ciloleucel +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03391466
NCT03391466Phase 3Completed
CompareCT.gov

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)

Kite, A Gilead Company·interventional·Posted Jan 5, 2018·Updated Dec 1, 2025

In Brief

A Phase 3 clinical trial evaluating Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, and 2 other interventions for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Completed, enrolled 359 participants across 72 sites in 14 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 5, 2018
Enrollment StartJan 25, 2018
Primary CompletionMar 18, 2021
Study CompletionNov 25, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.5 years ago

Interventions

Axicabtagene Ciloleucelbiological

Administered intravenously

Platinum-containing Salvage Chemotherapydrug

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).

Cyclophosphamidedrug

Administered intravenously

Fludarabinedrug

Administered intravenously