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

Trial Profile

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: 11 Sep 2017

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
  • Most Recent Events

    • 11 Sep 2017 According to an ERYtech Pharma media release,this study is on track for primary results by the end of this year.
    • 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.
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