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)

Indication and most important 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.

Short description of intervention

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.

Type of study

First line trial

Current status

Recruitment complete - In follow-up

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'

Principal investigator

Stephen O'Brien, MD
SPIRIT Trial Office
International Centre for Life
Newcastle upon Tyne, UK

Additional information

Short protocol in European LeukemiaNet

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