Table 1 Timeline of events from trial opening to adding the new arms
Date | Task |
|---|---|
Q3 2014 | Stage 1 open to recruitment September 2014: FCR vs IR |
Q3 2015 | Emerging response data for venetoclax FLAIR recruiting ahead of target Decision to progress amendment |
Q4 2015 | Initial DMEC/TSC review and provisional approval CRUK amendment application AbbVie funding application NCRI CSG review |
Q1 2016 | AbbVie agreed to support amendment subject to contract |
Q2 2016 | CRUK approval Janssen agreed to support amendment subject to contract Protocol amendments began |
Q1 2017 | Amendments to protocol and PIS finalised DMEC/TSC final approval MHRA substantial amendments submitted |
Q2 2017 | Ethics substantial amendments submitted Preliminary safety data for I+V became available CRFs and database amendments finalised Contracts signed and all approvals had been received |
Q3 2017 | Stage 2 open to recruitment: FCR vs IR vs I vs I+V Amendment randomisation became live July 2017 Original randomisation system switched off August 2017 |