Urgent Safety Measure
The Sponsor had been notified of an interruption in supply of Vindesine in the UK. Vindesine was out of stock in the UK due to high levels of demand. Vindesine is given as part of the GPOH regimen in the induction randomisation arm (the other arm of this randomisation, Rapid COJEC, is unaffected). The Sponsor and the UK Lead Coordinating Investigator made the decision to substitute vindesine with vincristine until normal supply of vindesine resumes. The MHRA were informed about this (05-Apr-2023) and an Urgent Safety Measure was authorised. The REC was informed of this via email on 05-Apr-2023.