LI-1

• Research type

  Research Study

• Full title

  A programme of development for older patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome

• IRAS ID

  69877

• Eudract number

  2011-000749-19

• ISRCTN Number

  pending

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  PaW-1 will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years for whom conventional chemotherapy is not considered suitable. The Trial is part of a continuous Programme of Development aimed at improving the outcomes of treatment in this patient population.Patients will be randomised between an established approach to non-intensive treatment, namely Low Dose Ara-C (LD Ara-C), versus one of four novel treatments, which are Sapacitabine or Vosaroxin or Vosaroxin combined with LD Ara-C or AC220 combined with LDAra-C.

• REC name

  Wales REC 3

• REC reference

  11/WA/0053

• Date of REC Opinion

  4 May 2011

• REC opinion

  Further Information Favourable Opinion