About
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 study opened for recruitment in June 2005.
All patients will be randomised in equal proportions to one of
the following three treatment groups:
- a) Imatinib monotherapy 400 mg daily
- b) Imatinib monotherapy 800 mg daily
- c) Imatinib 400 mg daily plus 180 μg/wk pegylated interferon,
Arm C Closed for recruitment in February 2008
Protocol amendment 2 (protocol version 16) closed recruitment to
ARM C - Patients randomised to the trial following approval of
amendment 2 will be randomised to either receive 400mg or 800mg
daily imatinib. Patients randomised to Arm C prior to amendment 2
will continue to receive their randomised study treatment according
to the protocol.
The primary endpoint is to compare overall survival in the three
arms at 5 years, with a secondary endpoint of 'molecular response'
one year.
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 SPIRIT1 websystem which allows recruitment of
patients at that site to commence.
SPIRIT1 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).
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