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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06646978

Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
787 (estimated)
Sponsor
Poitiers University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGImatinib (STI571)Imatinib-based regimen

Timeline

Start date
2024-05-01
Primary completion
2025-05-01
Completion
2025-05-01
First posted
2024-10-17
Last updated
2024-10-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06646978. Inclusion in this directory is not an endorsement.