SPIRIT 2 is a Phase III, multicentre, open-label, prospective randomised trial comparing imatinib 400 mg daily versus dasatinib 100 mg daily in patients with newly-diagnosed chronic phase Chronic Myeloid Leukaemia (CML).
The study opened in August 2008, closed to recruitment in 2013 and recruited 814 patients.
Patients will be randomised in equal proportions to one of the following treatment groups:a) Imatinib 400 mg daily
b) Dasatinib 100 mg daily
The primary endpoint is to compare Event Free Survival (EFS) between the two arms at 5 years.
SPIRIT 2 is a paperless trial and all data will be collected electronically.