Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT01460693
Status:
COMPLETED
Last Update Posted:
2018-04-24
First Post:
2010-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Imatinib Versus Dasatinib in Patients With Newly-diagnosed Chronic Phase Chronic Myeloid Leukaemia
Sponsor:
Newcastle University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRIT2
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: