Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 787
- 试验地点
- 1
- 主要终点
- Risk of second primary malignancies (SPM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included in the French SPIRIT trial
排除标准
- 未提供
研究组 & 干预措施
Patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial
干预措施: Imatinib (STI571) (Drug)
结局指标
主要结局
Risk of second primary malignancies (SPM)
时间窗: 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.
次要结局
- Treatment strategies for CML and SPM at their occurrence(At the occurence of SPM. Through study completion, on average 20 years)