Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

Official Title

A Phase II, Single Arm, Multicentre Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)


This is a multi-centre, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

Trial Description

Primary Outcome:

  • Overall Response Rate (ORR)
Secondary Outcome:
  • Incidence and severity of adverse events (AEs)
  • Time to response (TTR)
  • Duration of overall response (DOR)
  • Event free survival (EFS)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • In vivo cellular Pharmacokinetic (PK) profile of CTL019 transduced cells into target tissues
  • Incidence of immunogenicity to CTL019
  • Number of Participants with presence of exposure to replication-competent lentivirus (RCL) as Assessed by quantitative polymerase chain reaction (qPCR)
  • Prevalence of immunogenicity to CTL019

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society