Single-Arm PharmacoKinetic/PharmacoDynamic and Safety Study of Eryaspase (GRASPA) for Patients With Hypersensitivity to PEG-Asparaginase, Diagnosed With Ph(-) Acute Lymphoblastic Leukemia

Trial Profile

Single-Arm PharmacoKinetic/PharmacoDynamic and Safety Study of Eryaspase (GRASPA) for Patients With Hypersensitivity to PEG-Asparaginase, Diagnosed With Ph(-) Acute Lymphoblastic Leukemia

Discontinued
Phase of Trial: Phase II

Latest Information Update: 24 Jun 2018

At a glance

  • Drugs ERY-ASP (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Acronyms NOR-GRASPALL 2016
  • Most Recent Events

    • 24 Jun 2018 Status changed from recruiting to discontinued, according to a ERYtech Pharma media release.
    • 24 Jun 2018 According to a ERYtech Pharma media release, the company has ceased the development of Eryaspase in Acute Lymphoblastic Leukemia (ALL)including the withdrawal of its European MAA, based on recent feedback from the regulatory agencies in Europe and the United States, which states that, the company would require an additional investment in order to seek regulatory approval of eryaspase for the treatment of ALL.
    • 20 Feb 2018 Planned End Date changed from 1 Aug 2019 to 1 Aug 2020.
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