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)

Summary:

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

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society