SPIRIT 1 was 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 was 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 trial has now been closed down and archived.
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