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).
Below are the most recent versions of important documentation. Please goto the document center for more.
- last updated 20 March 2008
Patient Information Sheet / Consent Form v1.2
- last updated 07 May 2008
SAE Form v2.0
- last updated 01 August 2009
Information for pharmacists v2.0
- last updated 14 October 2011
Dasatinib order form v3.0
- last updated 23 June 2011
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