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Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

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Trial Profile

Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 04 Feb 2022

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At a glance

  • Drugs ERY-ASP (Primary) ; Asparaginase
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GRASPALL; GRASPIVOTALL
  • Sponsors ERYtech Pharma

Most Recent Events

  • 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.
  • 05 Jun 2018 Results presented at the 54th Annual Meeting of the American Society of Clinical Oncology
  • 04 Jun 2018 According to an ERYtech Pharma media release, pharmacodynamic characterization data from this trial will be presented at the American Society of Clinical Oncology (ASCO) annual meeting (June 2018).

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