At long last, the DESTINY study is now officially open, as of Friday. Liverpool Royal University Hospital (Prof. Richard Clark is the lead investigator of this UK study) seeing their first patients for screening on Monday- i.e today.
The Liverpool Trials Team will now be focussing on getting the other 20 study sites open nationally. This will help open up the sites more quickly but it will ultimately depend on the individual local R & D approval. If you want to enrol in this study and you know your treatment centre is taking part, then you should contact them directly and get your name on the list.
The DESTINY trial will evaluate the feasibility of de-escalation and then stopping treatment in chronic myeloid leukaemia patients with excellent responses to prior treatment. DESTINY is conceived as a pilot for including this strategy in the next phase III study for the UK (to be known as SPIRIT3). Patients are eligible if in first chronic phase; have been treated with imatinib, dasatinib or nilotinib for at least 3 years from original diagnosis; and whose BCR-ABL1 levels have been at or below 0.1% on all tests for the past 12 months. Two groups will be studied; those in whom BCR-ABL1 has been undetectable for at least 12 months in at least 3 samples, all of which have at least 104 control transcripts (molecular remission at the 4-log level, abbreviated as the ‘MR4’ group), and those in whom BCR-ABL1 is detectable on some or all tests in the past 12 months, but always below a level of 0.1% (major molecular response, abbreviated to the ‘MMR’ group). Both MR4 and MMR groups will be treated identically though analysed separately, by initially de-escalating treatment to 50% of the standard dose for 12 months. If the BCR-ABL1 level remains at or below 0.1%, treatment is then completely stopped, and observation continues for a further 24 months. The objective of DESTINY is to determine the safety and efficacy of initially de-escalating and then stopping TKI treatment, in CML patients with either undetectable disease or with stable MMR. (from UKCRN Portfolio)