SPIRIT 3

SPIRIT 3 was a phase III, randomised, open-label, non-inferiority trial for patients newly diagnosed with Chronic Myeloid Leukaemia (CML). It intended 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 was terminated due to withdrawal of funding. Although this is very disappointing for the trial team and the CML community, there was a development which would have made the trial very difficult to run across the UK. NHS England and Scotland had competitive tenders out to procure generic imatinib for a January 2017 start and there were a number of potential generic imatinib suppliers for the UK. It seemed likely that the price of generic imatinib will be considerably lower than Glivec. It would therefore have been 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.