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: 06 Nov 2017

At a glance

  • Drugs Tisagenlecleucel-T (Primary)
  • Indications Acute lymphoblastic leukaemia; B cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ELIANA
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Nov 2017 According to a Novartis media release, baesed on the data from ELIANA and JULIET studies a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
    • 30 Aug 2017 According to a Novartis media release, the US FDA has approved CTL019 (tisagenlecleucel) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. The FDA approval is based on the results of this trial.
    • 24 Jul 2017 Planned End Date changed from 1 Jan 2023 to 3 Mar 2022.
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