Standard acute-myeloid-leukaemia paediatric investigation plan

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Download document Standard acute-myeloid-leukaemia paediatric investigation plan
Reference number EMA/288890/2011
Status draft: consultation closed
First published 22/02/2013
Last updated 22/02/2013

Summary

The standard paediatric investigation plan (PIP) for acute myeloid leukaemia (AML) aims to highlight the persistent unmet therapeutic needs for AML in children, to propose plausible targets and mechanisms of action that could address these needs, to set out the principal features of trials in children with AML, and to make the possible requirements for a PIP for AML transparent. The standard PIP is a starting point for discussions on paediatric AML development.