A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Trial Profile

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Mar 2018

At a glance

  • Drugs Tisagenlecleucel (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ENSIGN
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 16 Mar 2018 Status changed from recruiting to active, no longer recruiting.
    • 12 Dec 2017 Outcomes of cellular kinetic model developed using pooled data (n=90) from two phase 2 studies (ELIANA and ENSIGN), assessing the impact of Tocilizumab, clinically relevant intrinsic and extrinsic factors on CTL019 cellular kinetics and correlates for cytokine release syndrome severity,presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 12 Dec 2017 Results of a pooled analysis of ELIANA and ENSIGN trials (n=97) assessing the impact of Humoral Immunogenicity on CTL019 Cellular Kinetics, Efficacy, and Safety, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
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