An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501489-24-00

Acronym

KT-US-484-0136

Enrollment

127

Registered

2023-08-28

Start date

2025-03-28

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line treatment of adult subjects with high-risk large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) and high-grade B-cell lymphoma (HGBL).

Brief summary

Event-free survival (EFS) by blinded central assessment.

Detailed description

Progression-free survival (PFS) by blinded central assessment., Overal survival (OS), PFS by investigator assessment., Complete remission (CR) rate by blinded central assessment., Incidence of adverse events (AEs), serious adverse events (SAEs), deaths, and clinically significant changes in safety laboratory values, Patient-reported outcome (PRO)-QOL as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29), and European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L).

Interventions

DRUG-

DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-free survival (EFS) by blinded central assessment.	—

Secondary

Measure	Time frame
Progression-free survival (PFS) by blinded central assessment., Overal survival (OS), PFS by investigator assessment., Complete remission (CR) rate by blinded central assessment., Incidence of adverse events (AEs), serious adverse events (SAEs), deaths, and clinically significant changes in safety laboratory values, Patient-reported outcome (PRO)-QOL as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29), and European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L).	—

Measure

Time frame

—

Countries

Austria, France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026