Idasanutlin in relapsed/refractory AML

• Research type

  Research Study

• Full title

  A multicenter, double-blind, randomized, placebo-controlled, phase III study of idasanutlin, an mdm2 antagonist, with cytarabine versus cytarabine plus placebo in patients with relapsed or refractory acute myeloid leukaemia (aml).

• IRAS ID

  195792

• Contact name

  Steve Knapper

• Contact email

  KnapperS@cardiff.ac.uk

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2014-003065-15

• Clinicaltrials.gov Identifier

  NCT02545283

• Duration of Study in the UK

  4 years, 6 months, days

• Research summary

  The purpose of this study is to compare the effects, good or bad, of idasanutlin plus cytarabine (chemotherapy) versus placebo (an inactive substance that looks like idasanutlin) plus cytarabine on patients with acute myeloid leukaemia to find out which is better.

• REC name

  Wales REC 2

• REC reference

  16/WA/0060

• Date of REC Opinion

  8 Apr 2016

• REC opinion

  Further Information Favourable Opinion