Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
Status:
Completed
Trial end date:
2018-03-07
Target enrollment:
Participant gender:
Summary
Imatinib 400mg daily is the current NICE-approved standard treatment for newly diagnosed
Chronic Myeloid Leukaemia (CML). 5 yr follow up of CML patients treated in this way indicates
an 89% probability of progression-free survival. Imatinib is not tolerated or effective in
some patients however, and a proportion of patients become resistant to the drug. SPIRIT 2
study aims to establish whether a new drug, dasatinib, is superior to imatinib in terms of
event free survival and therefore will be an effective first-line therapy for newly-diagnosed
CML patients. This study will also provide crucial long-term survival, quality of life and
health economic data to assist health care providers and managers to determine the most
cost-effective drug therapy for CML.
Phase:
Phase 3
Details
Lead Sponsor:
Newcastle University
Collaborators:
Bristol-Myers Squibb Hammersmith Hospitals NHS Trust Institute of Cancer Research, United Kingdom Newcastle-upon-Tyne Hospitals NHS Trust