SPIRIT 3 is a phase III, randomised, open-label, non-inferiority trial for patients newly diagnosed with Chronic Myeloid Leukaemia (CML). It intends to investigate the possibility of optimising treatment for CML and assess whether it is possible to reduce or stop treatment once a certain level of response had been achieved.
As of September 2016 SPIRIT 3 has been terminated due to withdrawal of funding. Although this is very disappointing for us and the CML community, there has been another development recently which would have made the trial very difficult to run across the UK. NHS England and Scotland have competitive tenders out to procure generic imatinib for a January 2017 start and there are a number of potential generic imatinib suppliers for the UK. It seems likely that the price of generic imatinib will be considerably lower than Glivec. It would therefore be very difficult to ask Trusts to participate in a trial involving a randomisation between an inexpensive generic imatinib and other considerably more expensive TKIs, even if all drugs were NICE approved.