Compliance to Long Term Imatinib Therapy in Newly Diagnosed Patients With Chronic Myeloid Leukaemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first clinical trials were conducted in 1998 in patients with advanced disease, and by 2002 imatinib was established as the standard therapy for all patients including those recently diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more knowledge about issues related to long term treatment with imatinib such as why some patients respond better than others, the development of side effects and the quality of life.
详细描述
We plan to follow prospectively a cohort of CML patients in order to study their compliance to therapy,pharmacological levels of imatinib and the prevalence of side effects. We expect to be able to correlate the actual dose received, the pharmacological levels of drug in blood, with the change in the level of residual disease (measured by Q-PCR) at various time points. We also want to gain insight into the relationship between compliance to therapy and specific side effects and between compliance and duration of treatment. We will also assess the adherence to imatinib therapy after increases in the drug dose that are part of standard treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with CML who have been treated with imatinib (Glivec®) within 6 months of diagnosis as first line therapy. Initial therapy with hydroxyurea is permitted.
排除标准
- •Unable to give consent.
- •Unable to communicate with the medical and nursing staff
研究组 & 干预措施
1
Patients with CML who have been treated with Imatinib (Glivec) within 6 months of diagnosis as first line therapy. Initial therapy with Hydroxyurea is permitted
干预措施: Imatinib (Drug)