Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial (K2SPIRIT)

Poitiers University Hospital

Status: Invitation-only

Conditions: Chronic Myeloid Leukemia (CML)

Treatments: Drug: Imatinib (STI571)

Study type: Observational

Funder types: Other

Identifiers

NCT06646978

K2SPIRIT

Details and patient eligibility

About

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.

Enrollment: 787 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Included in the French SPIRIT trial

Exclusion criteria

• None

Trial design

787 participants in 1 patient group

Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial

Treatment:

Drug: Imatinib (STI571)