A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome

• Research type

  Research Study

• Full title

  A Trial for Older Patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome

• IRAS ID

  127379

• Contact name

  Kathy Pittard-Davies

• Contact email

  davieskp2@cardiff.ac.uk

• Sponsor organisation

  Cardiff University

• Eudract number

  2013-002730-21

• ISRCTN Number

  ISRCTN31682779

• Duration of Study in the UK

  5 years, 11 months, 31 days

• Research summary

  The AML18 Trial will evaluate several therapeutic questions in Acute Myleoid Leukaemia (AML). The trial will recruit 1600 patients primarily over the age of 60 who are considered fit for an intensive approach to treatment.
  A randomisation will compare standard chemotherapy schedule Daunorubicin/Ara-C(DA) combined with 1 or 2 doses of Mylotarg in course 1, patients who fail to achieve CR or are MRD positive after course 1 will be randomised to compare DA with DA plus Cladribine or Flag-Ida for up to 2 courses of therapy. For patients with known adverse risk cytogenetics will enter a randomisation to compare DA versus Vosaroxin and Decitabine.
  Patients who achieve CR after course 1 will be randomised after a further course of DA to receive either DA or IDAC in course 3 . At course 2 patients will also be randomised to receive AC220 versus no AC220 with or without maintenance.

• REC name

  Wales REC 3

• REC reference

  13/WA/0205

• Date of REC Opinion

  17 Sep 2013

• REC opinion

  Further Information Favourable Opinion