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
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 14 Jul 2017
At a glance
- Drugs ERY-ASP (Primary) ; Cytarabine
- Indications Acute myeloid leukaemia; Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms ENFORCE; ENFORCE 1; GRASPA-ML
- Sponsors ERYtech Pharma
- 10 Jul 2017 Planned End Date changed from 1 Mar 2017 to 1 Oct 2017.
- 10 Jul 2017 Planned primary completion date changed from 1 Mar 2017 to 1 Oct 2017.
- 10 Jun 2017 Biomarkers information updated