Phase III B in Acute Lymphoblastic Leukemia

Official Title

Phase IIIb Study for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019

Summary:

This is a single arm, open-label, multi-centre, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell ALL.

Trial Description

Primary Outcome:

  • Number of participants with Adverse Events (AEs)
Secondary Outcome:
  • Complete Remission (CR)
  • Percentage of patients who achieve CR or CRi at Month 6 without step cell transplantation (SCT)
  • Percentage of patients who achieve CR or CRi and then proceed to SCT while in remission prior to month 6
  • Duration of response (DOR)
  • Relapse-free survival (RFS)
  • Event-free survival (EFS)
  • Overall survival (OS)
  • Prevalence and incidence of immunogenicity of antibodies against CTL019
  • Persistence of CTL019 in the blood
  • Correlation of Cmax and AUC0-28d of CTL019 in the blood with CRS grade
  • Percentage of patients attaining CR or CRi at Day 28
  • Response as a function of baseline tumour burden (tumour load) (minimal residual disease (MRD), extramedullary disease, etc.)
  • Maximum concentration (Cmax) kinetic parameter of CTL019 in the blood
  • Time to peak concentration (Tmax) kinetic parameter of CTL019 in the blood
  • Area under the curve (AUC) kinetic parameter of CTL019 in the blood
  • MRD quantitative result (% leukemic cells) and qualitative result

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