SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia Scientific title
Study title
SPIRIT2 = Comparison of imatinib versus dasatinib in patients with newly-diagnosed chronic phase chronic myeloid leukaemia [Europe]
Scientific title
A Phase III, Prospective Randomised Comparison of Imatinib 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia (EudraCT 2007-006185-15, ClinicalTrials.gov NCT01460693)
Type of study
First line trial
Current status
Recruitment complete – In follow-up
What is the purpose of the study
Comparison of 5-year event free survival between two treatment arms receiving either dasatinib 100mg or imatinib 400mg. The study aim is to show superiority of the dasatinib arm over the imatinib arm.
Key inclusion criteria
Patients can be enrolled within 3 months of initial diagnosis of chronic phase CML and cytogenetic confirmation of Philadelphia chromosome or variants of (9;22) translocations. Patients should be non-treated with any TKI (eg imatinib, dasatinib, nilotinib), busulphan, interferon-alpha, homoharringtonine, cytosine arabinoside, or any other investigational agents.
Key exclusion criteria
Where can I find additional information
Study sponsor
Newcastle-upon-Tyne NHS Hospitals (Main Sponsor),
Bristol-Myers Squibb (Funder)
Scientific lead / contact
O’Brien, MD, Stephen
Newcastle University Medical School
stephen.o’brien@newcastle.ac.uk
Principal investigator
Stephen O’Brien, MD
SPIRIT Trial Office
International Centre for Life
Newcastle upon Tyne, UK
Study centers / principal investigators
> 150 study centres
Members of trial management committee are based at:
Newcastle upon Tyne, UK
Newcastle University Medical School
Liverpool, UK
Royal Liverpool University Hospital
London, UK
Imperial College London