Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

Official Title

A Phase 2 Multicentre Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)

Summary:

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma.

Trial Description

Primary Outcome:

  • Complete Response (CR) Rate
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Event-Free Survival (EFS)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Percentage of participants experiencing adverse events and Clinical Significant Changes in Safety Lab Values
  • Relapse with Central Nervous Disease (CNS) Disease
  • Levels of anti-CD19 CAR T cells in blood
  • Levels of cytokines in serum

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society