Use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies - Scientific guideline

This document describes the basis and regulatory requirements for the use of minimal residue disease as an intermediate endpoint to predict clinical benefit in trials in chronic lymphocytic leukaemia.

Keywords: Minimal residual disease (MRD), chronic lymphocytic leukaemia (CLL)

Current effective version

Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies

Draft: consultation closed Consultation dates: 15/12/2014 to 30/06/2015 Reference Number: EMA/629967/2014 Summary:

The scope of this document is to describe the basis and regulatory requirements for the use of minimal residue disease (MRD) as an intermediate endpoint to predict clinical benefit in trials in chronic lymphocytic leukaemia (CLL). At present, this guidance is not applicable to other clinical settings.

Document history

Overview of comments received on 'Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies'

Reference Number: EMA/480192/2015