Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Official Title

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


The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Trial Description

Primary Outcome:

  • Event Free Survival (EFS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Overall Survival (OS)
  • Modified Event Free Survival (mEFS)
  • Progression-Free Survival (PFS)
  • Duration of Response (DOR)
  • Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.
  • Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains
  • Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)
  • Changes over time in the Visual analog scale (VAS) scores
This is a phase 3 randomized, open-label, multicentre study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy. Standard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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