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Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Study acronym: ZUMA-23
StatusActive, Not Recruiting
PhasePhase 3
Started2023-02-10
View on ClinicalTrials.gov ↗

Amendment history

2026-04-14
Study Status, Contacts/Locations v37
Trial status changed: Recruiting → Active, Not Recruiting
Trial sites reduced: 90 → 85 locations
2026-03-02
Study Status, Contacts/Locations v36
Study sitesdetails revised at 2 of 90 sites
2025-10-08
Study Status v35
Re-verified, no change to tracked fields
2025-08-20
Study Status, Contacts/Locations v34
Study sitesdetails revised at 1 of 90 sites
2025-05-16
Study Status, Contacts/Locations v33
Study sitesdetails revised at 83 of 90 sites
Show 32 earlier versions
2024-12-20
Study Status, Contacts/Locations v32
Study sites87→90
2024-12-05
Study Status, Contacts/Locations v31
Study sites84→87
2024-11-04
Study Status, Contacts/Locations v30
Study sites76→84
2024-10-10
Study Status, Contacts/Locations v29
Study sites74→76
2024-09-16
Study Status, Contacts/Locations v28
Study sites70→74
2024-08-16
Study Status, Contacts/Locations v27
Study sites65→70
2024-07-12
Study Status v26
Re-verified, no change to tracked fields
2024-06-13
Study Status, Contacts/Locations v25
Study sites64→65
2024-05-22
Study Status, Contacts/Locations v24
Study sites63→64
2024-04-23
Study Status, Contacts/Locations v23
Study sites61→63
2024-04-02
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v22
Study sites51→61
Eligibility criteria+112 characters
[...] tween DLBCL and classical Hodgkin lymphoma Burkitt lymphoma History of Richter's transformation of chronic lymphocytic leukemia Presence of detectable cerebrospinal fluid (CSF)-malignant c [...] erentiation 4 (CD4) count > 200 cells/uL. Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy o [...]
Secondary endpoints9 entries, revised
Progression-free Survival (PFS) by InvestigatorBlinded Central Assessment PFS by CentralInvestigator Assessment Complete Response (CR) Rate by Blinded Central Assessment
Primary endpoints1 entry, revised
Event-free Survival (EFS) by Blinded Central Assessment
Study description-27 characters
Five years after the last study participant is randomizedrandomization, participants who have received axicabtagene ciloleucel wil [...]
2024-02-21
Study Status, Contacts/Locations v21
Study sites50→51
2024-02-02
Study Status, Contacts/Locations v20
Study sites45→50
2024-01-23
Study Status, Contacts/Locations v19
Study sites39→45
2024-01-04
Study Status, Contacts/Locations v18
Study sites38→39
2023-12-18
Study Status, Contacts/Locations v17
Study sites35→38
2023-12-05
Study Status, Contacts/Locations v16
Study sites34→35
2023-11-16
Study Status, Contacts/Locations v15
Study sites25→34
2023-10-18
Study Status, Contacts/Locations v14
Study sites19→25
2023-09-21
Study Status, Contacts/Locations v13
Study sites16→19
2023-09-06
Study Status, Contacts/Locations v12
Study sites13→16
2023-08-18
Study Status v11
Re-verified, no change to tracked fields
2023-08-02
Study Status, Contacts/Locations v10
Study sites11→13
2023-07-14
Study Status, Contacts/Locations v9
Study sites10→11
2023-06-27
Study Status, Contacts/Locations v8
Study sites9→10
2023-06-07
Study Status, Contacts/Locations v7
Study sites6→9
2023-05-04
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 6 sites
2023-04-17
Study Status, Contacts/Locations v5
Study sites5→6
2023-03-30
Study Identification, Study Status, Study Description, Contacts/Locations v4
Study sites3→5
Study title-2 characters
A Study to Compare Axicabtagene Ciloleucel With Standard of Ca [...]
2023-02-27
Study Status v3
Start dateestimated 2023-02→confirmed 2023-02-10
2023-02-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→3
2022-12-13
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, References v1
Start date2022-11→2023-02
Eligibility criteria-2,320 characters
[...] otherwise specified (NOS) High-grade B-cell lymphoma (HGBL) (including HGBL with MYC and BCL2 and/or BCL6 rearrangements (DHL/THL) based on Fluorescence in situ hybridization (FISH) analysis, and High-grade B cell lymphoma not otherwise specified (HGBL-NOS). Note: Transformed DLBCL from follicular lymphoma or from ma [...] if no prior treatment with anthracycline-containing regimen. High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis. Ann Arbor Stage III or IV disease. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the ti [...] [...]
Secondary endpointsdetails revised at 2 of 9 entries
2022-10-31
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Non-Hodgkin Lymphoma
1,512 trials monitored
See 79 trials at risk
DLBCL
648 trials monitored
See 32 trials at risk
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Trial Details
NCT Number NCT05605899
Lead Sponsor Kite, A Gilead Company
Conditions High-risk Large B-cell Lymphoma (LBCL)
Enrollment 300 participants
Start Date 2023-02-10
Primary Completion 2031-03 (estimated)
Study Completion 2031-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-15