The STATIC team have released an update which is on the CLL Support website.
In brief, there will be no patient choice arm so patients cannot elect to continue Ibrutinib.
"We have made some changes in the STATIC trial design due to a variety of reasons, including feedback from the funders of STATIC, the National Institute of Health Research Healthcare Technology Assessment Programme, but also with the emergence of the initial results from the FLAIR trial and other trials indicating the continuing risk of increasing toxicity with prolonged time on ibrutinib and that some patients stopping ibrutinib for toxicity have prolonged periods before needing further treatment.
The principle modification in STATIC is that the patient choice group was felt to be inappropriate, particularly as any patient randomised to the intermittent treatment arm of STATIC would go back on ibrutinib at the first sign of their CLL returning. This modification was done with input from the UK CLL patient organisations as well as UK CLL experts.
We want to reassure everyone wanting to take part in STATIC when they finish 6 years of ibrutinib treatment in FLAIR that STATIC includes a “randomisation trial” and “clinical need group”. The trial is designed in such a way that the participants who would not be considered appropriate for the randomisation trial, for example if their blood count is not at acceptable levels, could receive the drug in the “clinical need group”.
The “randomisation trial” will be only recruiting participants who are in clinical remission as defined by the trial protocol. All participants from FLAIR trial who have already finished six years of ibrutinib will be able to participate in the trial, if they choose, with the same criteria as those patients from FLAIR still on treatment."
More details here:
images.cllsupport.org.uk/ht...
Jackie
