SPIRIT 1 is a Phase III, multicentre, open-label, prospective randomised trial comparing imatinib alone at 400 versus 800 mg daily versus imatinib 400mg daily plus interferon-alpha in patients with newly-diagnosed chronic phase CML.
The primary endpoint is to compare overall survival in the three arms at 5 years, with a secondary endpoint of 'molecular response' at one year.
The study opened for recruitment in June 2005. Arm C – imatinib 400mg daily plus interferon-alpha closed early, in February 2008 and study recruitment closed in February 2009.
The team are now contacting sites to arrange study close down. Please do not archive the study until you have received the confirmation of closure letter from the Trial Office.