Phase 3 Study of Elacytarabine in late stage AML

• Research type

  Research Study

• Full title

  A Randomised Phase III Study of Elacytarabine vs. Investigator’s Choice in Patients with Late Stage Acute Myeloid Leukaemia

• IRAS ID

  53570

• Contact name

  Michael Dennis

• Sponsor organisation

  Clavis Pharma

• Eudract number

  2009-014445-80

• Research summary

  This multicentre Phase III study will focus on patients with late stage Acute Myeloid Leukaemia (AML) that have failed/relapsed from 2 or 3 previous induction regimens. For second relapse AML patients no standard therapy is available and prognosis is poor. Most of these patients are offered supportive care, repetitions of cytarabine-based combination or investigational therapies. Elacytarabine is a novel chemical entity, a fatty acid derivative of cytarabine which is used in the treatment of AML. In the Phase II clinical studies of late stage AML it was shown to have superior survival and remission rates. These encouraging results justified the following Phase III study. The goal of this clinical research is to find out if elacytarabine is effective, well tolerated and safe for the treatment of late stage AML. The study drug will be compared with the treatment that's the investigator's choice. Approximately 65 hospitals and cancer centres worldwide will consent and enroll roughly 350 AML patients that will be randomised to either:- Elacytarabine- Investigator's Choice Patients will receive 1-2 treatment courses for remission induction and if remission is attained, 1-2 courses of consolidation. Patients who benefit from the treatment may receive repeated courses of the study drug, even if remission is not attained.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/51

• Date of REC Opinion

  20 Jul 2010

• REC opinion

  Further Information Favourable Opinion