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

NCT06646978 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 787

Last updated 2024-10-17

No results posted yet for this study

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

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

Imatinib (STI571)

Imatinib-based regimen

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646978 on ClinicalTrials.gov