About

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 and it is expected that 810 patients will be entered into the study over the next 3-4 years.

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.

Patients must be newly diagnosed (<3 months) and have been treated with only hydroxycarbamide (hydroxyurea) and/or anagrelide.

Any interested site in the UK can register for the trial by contacting the SPIRIT Trial Manager (see contacts).

All documentation required for study set-up can be found in the Documents section of this website. Once a site has gained ethical approval and local Trust Research and Development approval it is activated on the SPIRIT 2 web system which allows recruitment of patients at that site to commence.

SPIRIT 2 will be a paperless trial and all data will be collected electronically.

If you require further information please contact the SPIRIT Trial Manager or a member of the Study Management Committee (see contacts).