A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy
Phase of Trial: Phase II
Latest Information Update: 16 Feb 2018
At a glance
- Drugs ERY-ASP (Primary) ; Cytarabine
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms ENFORCE; ENFORCE 1; GRASPA-ML
- Sponsors ERYtech Pharma
- 14 Dec 2017 Status changed from active, no longer recruiting to completed.
- 08 Dec 2017 According to an ERYtech Pharma media release, the full dataset will be discussed at a scientific congress in 2018.
- 08 Dec 2017 Primary endpoint has not been met. (Overall survival)