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

• Conditions: Chronic Myeloid Leukemia (CML)
• Interventions: Drug: Imatinib (STI571)

• Registration Number: NCT06646978
• Lead Sponsor: Poitiers University Hospital

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

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 787

Inclusion Criteria

• Included in the French SPIRIT trial

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial	Imatinib (STI571)	-

Primary Outcome Measures

Name	Time	Method
Risk of second primary malignancies (SPM)	Through study completion, an average of 20 years	SPM is an invasive primary cancer diagnosed at least 6 months after CML diagnosis. Non-melanoma skin cancers were excluded from the analysis.

Secondary Outcome Measures

Name	Time	Method
Treatment strategies for CML and SPM at their occurrence	At the occurence of SPM. Through study completion, on average 20 years	For treatment strategy of CML: response, modification of treatment (temporary discontinuation, permanent interruption, replace by a new generation TKI), relapse.; For treatment strategy of SPM: intent of treatment (curative, palliative, follow without treatment), type of treatment (surgery, radiotherapy, chemotherapy, targeted therapy), atypical adverses events, modification of treatment.

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France