SPIRIT 1 closing recruitment on 1st Feb 2009

12 January 2009

Dear colleagues,
We are intending to continue the transition from SPIRIT 1 to SPIRIT 2 and would like to let you know how this will happen. 

SPIRIT 1. We have recruited  256  patients to date and, with the advent of SPIRIT 2 and progress of the international SPIRIT trials, we intend to stop recruitment. SPIRIT 1 will stop recruitment on 1st February 2009. This decision was made at the suggestion of our independent Data Monitoring and Ethics Committee (DMEC). Please note that we wish to continue following up patients already recruited in the study and they will continue to receive their study medication in the usual way. You may wish to inform you local R&D office of the termination of recruitment.

Data from ASH on the French and German SPIRIT studies were presented at ASH and we have uploaded a summary on the SPIRIT 2 web site  http://www.spirit-cml.org. Interesting data from two studies comparing 400 vs 800 imatinib were also reported at ASH - again see the ASH summary document for more information.


SPIRIT 2. This is now the active NCRN national study and compares imatinib 400 vs dasatinib 100 in newly-diagnosed CML patients. If you are interested in participating and not yet going through set up, please contact the Trial Project Manager (Tel: 0191 282 4157, Email: chris.may@ncl.ac.uk) or Chief Investigator (s.g.o'brien@ncl.ac.uk).

Many thanks for your ongoing support for the SPIRIT studies. Lots more information and news items can be found on the SPIRIT web site: http://www.spirit-cml.org

Best wishes,
Dr Stephen G O'Brien
SPIRIT Chief Investigator
Chris May
SPIRIT Trial  Manager 
Tel: 0191 282 4157
Fax: 0191 376 0748
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Protocol - v 16

 - last updated 17 October 2007

SPIRIT Protocol - v14

 - last updated 23 March 2004

PIL/IC Form - v3

 - last updated 17 October 2007

Patient Booklet - How to take your study medication - v2

 - last updated 24 October 2007

Pharmacy manual - v7.0

 - last updated 10 June 2009

Prescription - Arm A - 400mg Imatinib - v2

 - last updated 19 January 2006

Prescription - Arm B - 800mg Imatinib - v2

 - last updated 19 January 2006

Prescription - Arm C - 400mg Imatinib + Pegasys - v3

 - last updated 08 January 2007
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