Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 3
- 主要终点
- Rate of Complete Cytogenetic Response (CCyR)
研究概览
简要总结
This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed
详细描述
Primary objectives
Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response :
- Complete hematologic response (CHR) at 3 months;
- Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases);
- Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale];
Assess the safety and tolerability of Cemivil after one year of treatment, based on:
- Incidence, severity, and relationship of adverse events (AEs) to the study medication;
- Serious AEs;
- AEs leading to permanent treatment discontinuation;
- Clinically relevant changes in laboratory tests (according to laboratory reference ranges).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Age ≥18 years
- •Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR
- •Written informed consent
排除标准
- •Age <18 years
- •CML in accelerated phase
- •CML in blast crisis
- •CML with mutation(s) in the BCR-ABL gene
- •Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)
结局指标
主要结局
Rate of Complete Cytogenetic Response (CCyR)
时间窗: 12 months
Rate of Major Molecular Response (MMR)
时间窗: 12 months
次要结局
- Incidence of treatment-emergent adverse events (AEs)(12 months)