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: Phase I
Latest Information Update: 15 Jul 2017
At a glance
- Drugs ERY-ASP (Primary)
- Indications Acute lymphoblastic leukaemia
- Focus Adverse reactions; Expanded access
- Acronyms EAP
- Sponsors ERYtech Pharma
- 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.
- 07 Nov 2014 Initial results to be presented at the 56th Annual Meeting and Exposition of the American Society of Hematology, according to an ERYtech Pharma media release.
- 31 Jul 2014 New trial record