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
Phase of Trial: Phase II/III
Latest Information Update: 10 Oct 2017
At a glance
- Drugs ERY-ASP (Primary) ; Asparaginase
- Indications Acute lymphoblastic leukaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms GRASPALL; GRASPIVOTALL
- Sponsors ERYtech Pharma
- 10 Oct 2017 According to an ERYtech Pharma media release, based on the data from this trial the company has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). The MAA resubmission also include additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA.
- 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).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History