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

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

Completed
Phase of Trial: Phase II/III

Latest Information Update: 10 Feb 2017

At a glance

  • Drugs ERY-ASP (Primary) ; Asparaginase
  • Indications Acute lymphoblastic leukaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GRASPIVOTALL
  • Sponsors ERYtech Pharma
  • Most Recent Events

    • 14 Nov 2016 According to an ERYtech Pharma media release, Company announces withdrawal of European MAA as it received received Day 180 List of Outstanding Issues (LOI) in Sep 2016 from CHMP's to provide the requested additional data regarding the comparability between the old and new form of asparaginase encapsulated in GRASPA, also the Company intends to resubmit the MAA mid-2017.
    • 10 May 2016 According to an ERYtech Pharma media release, the Marketing Authorization Application (MAA) for GRASPA to treat patients with relapsed and refractory (Acute-lymphoblastic-leukaemia) ALL, submitted in September 2015, is currently under review by the EMA's Commission for Human Medicinal Products (CHMP).
    • 08 Dec 2015 Results presented at the 57th Annual Meeting and Exposition of the American Society of Hematology
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