NCT01460693

Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

A Phase III, Prospective Randomised Comparison of Imatinib (STI571, Glivec/Gleevec) 400mg Daily Versus Dasatinib 100mg in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 814 (actual)
• Sponsor: Newcastle University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloid Leukemia, Chronic, Chronic Phase

Interventions

Type	Name	Description
DRUG	Imatinib	Oral Imatinib 100mg daily
DRUG	Dasatinib	Oral Dasatinib 100mg daily

Timeline

• Start date: 2008-08-01
• Primary completion: 2018-03-07
• Completion: 2018-03-07
• First posted: 2011-10-27
• Last updated: 2018-04-24

Locations

1 site across 1 country: United Kingdom