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

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Dec 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

    • 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)
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