Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA(R)) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
Phase of Trial: Clinical Phase Unknown
Latest Information Update: 12 Dec 2018
Price : $35 *
At a glance
- Drugs ERY-ASP (Primary)
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Adverse reactions; Expanded access
- Acronyms EAP
- Sponsors ERYtech Pharma
- 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.
- 24 Jun 2018 Status changed from recruiting to discontinued, according to a ERYtech Pharma media release.
- 05 May 2015 According to an ERYtech Pharma media release, an independent Data and Safety Monitoring Board (DSMB) completed its first safety assessment of this program and recommended continuation of the program without modification.