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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Mar 2024

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At a glance

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

    • Most Recent Events

    • 24 Aug 2022 According to an ERYtech Pharma media release, the company received feed back on iPSP (Initial Pediatric Study Plan), submitted in July 2022. After thorough evaluation of this feedback, which included a new request for additional data, and taking into account the changing competitive landscape in the treatment of hypersensitive ALL, the Company has determined that it is in the best interests of the Company and its shareholders to no longer seek approval for Graspa in ALL.
    • 25 Apr 2022 According to an ERYtech Pharma media release, the company is in a continued dialogue with the U.S. FDA regarding a potential BLA submission for GRASPA in hypersensitive ALL, which is expected in the third quarter of 2022, subject to FDA agreement on remaining outstanding information requests.
    • 06 Apr 2022 Results published in the ERYtech Pharma Media Release.

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