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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Oct 2017

At a glance

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

    • 12 Jul 2017 According to a Novartis media release, the US FDA Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
    • 25 Jun 2017 Results of pooled data from 2 trials (NCT02435849 and NCT02228096) assessing safety of Tisagenlecleucel-T presented at the 22nd Congress of the European Haematology Association
    • 25 Jun 2017 Results (n=79) of pooled analysis of ELIANA and ENSIGN studies assessing cellular kinetics, presented at the 22nd Congress of the European Haematology Association.
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