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Latest News

 

April 2026

 

Latest update:

 

RAMPART PARTICIPANTS CONTINUE IN FOLLOW-UP.

The current Protocol is dated version 8.0 March 2024. The main amendments from the previous version are:

  • The statistical design of RAMPART was modified in v7.0 and further modified in v8.0 and published. The decision to make these changes was made without knowledge of the accumulating trial data and has been agreed with all oversight committees. The modifications are described in section 9 of the protocol.
  • The Reference Safety Information (RSI) that should be used to determine expectedness of serious adverse reactions has also been updated. This is described in section 7.3.1.D.
  • Disease progression or death as a result of disease progression (with no involvement of study drugs) should not be reported on the AE Log (Form 06) or SAE CRF (Form 13). Instead, these events should be reported through the specific event forms, the Progression CRF (Form 10) and Death CRF (Form 12). It should be noted on these CRFs whether the event meets any of the seriousness criteria, as listed in table 16.

Across the UK, Australia, France and Spain between 2018 to June 2023, 790 patients were recruited. All participants completed treatment by June 2024 and are in long term follow-up as per protocol.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

 

As all trial participants are now in long-term follow-up, we would like to remind you all of the protocol requirements for reporting safety events, as documented in Section 7.0 of the RAMPART trial protocol (version 8.0). 

  1. SARs and SUSARs: These are events that are deemed by the Investigator to be at least possibly related to trial treatment. Please continue to report these events for all patients across both trial treatment arms (Arm B and C) until trial closure [using Form 13].

 

  1. SAEs no longer need to be reported as the timelines noted in the trial protocol have passed. These are events that are deemed by the Investigator to be unrelated to trial treatment. 

 

  1. Pregnancies no longer need to be reported. Pregnancies no longer need to be routinely reported as the timeline has passed.  In the event that there is a complication in a pregnancy that an Investigator determines is at least possibly related to trial treatment, it should be reported to the InCTU as a SAR [using Form 13].