Single-Arm PharmacoKinetic/PharmacoDynamic and Safety Study of Eryaspase (GRASPA) for Patients With Hypersensitivity to PEG-Asparaginase, Diagnosed With Ph(-) Acute Lymphoblastic Leukemia
Phase of Trial: Phase II
Latest Information Update: 19 Jan 2019
At a glance
- Drugs ERY-ASP (Primary)
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
- Acronyms NOR-GRASPALL 2016
- 31 Aug 2018 Biomarkers information updated
- 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.