Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646978
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K2SPIRIT
Brief Summary:
Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia CML CML has become a chronic disease requiring long-term administration of imatinib Late adverse effects were initially unknown Since 2005 imatinib has been suspected to increase the risk of second primary malignancies SPM Through the French STI571 Prospective Randomized Trial SPIRIT we studied the incidence of SPM after more than 20 years of exposure and treatment strategies for CML and SPM at their occurrence
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None