Nilotinib for Patients With Chronic Myeloid Leukemia in First Line and Any Subsequent Line - a Non-interventional Study on the Assessment of Deep Molecular Response in CML Patients in Daily Routine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Time to achievement of an MR4.0 and MR4.5
研究概览
简要总结
This was a non-interventional observational study within the routine chronic myeloid leukemia treatment practice; no further tests were required apart from the assessments routinely performed for Chronic myeloid leukemia patients treated with nilotinib.
详细描述
The observation period per patient was 24 months. All patients were treated with nilotinib in accordance to the clinical routine at the respective institution and the summary of product characteristics (SmPC).
The observation intervals (documentation at baseline and at about 3, 6, 9, 12, 18 and 24 months) were not fixed and were aligned with the regular treatment schedule and the clinical symptoms of each patient. The medical decision about the schedule as well as therapeutic and diagnostic measures was made solely by the responsible physician. Patients who discontinued treatment within two years of the observation period were followed until starting a new TKI therapy line, however with a maximum time period of six months. All other patients that reached the official end of treatment after completion of the 24-month observation period were followed up for 28 days.
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
- •Adult patients diagnosed with Ph+ CML (or evidence of BCR-ABL transcript) treated with nilotinib under routine medical practice and the SmPC, as amended, in first or any subsequent line, if the current therapy with nilotinib has not been in place for more than twelve months. Retrospective documentation of patients for up to one year will be permitted.
- •Patients who have already had an interruption/discontinuation of nilotinib therapy.
- •Patients who have been informed about this NIS and have personally dated and signed their informed consent form.
排除标准
- •There are no exclusion criteria, apart from the contraindications mentioned in the SmPC. Participating patients are not allowed to take part in a clinical trial in parallel,
结局指标
主要结局
Time to achievement of an MR4.0 and MR4.5
时间窗: 24 months
Time to achievement of an MR4.0 and MR4.5 was collected
Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory
时间窗: 24 months
Proportion of patients whose molecular response is routinely analyzed by a MR4.5-certified laboratory was collected
Patient-reported QoL
时间窗: 24 months
The EORTC QLQ-C30 questionnaire in conjunction with the EORTC QLQ-CML24 module was used to assess patient-reported QoL.
Patient adherence
时间窗: 24 months
Patient adherence was documented using the MMAS-8 (Morisky et al., 2008) patient questionnaire.
Proportion of patients in Major molecular response (MMR), and Deep molecular response according to international standard (MR^4.0 and MR^4.5)
时间窗: 24 months
Proportion of patients in MMR, MR\^4.0 and MR\^4.5 was collected
Duration of an MR4.0 and MR4.5
时间窗: 24 months
Duration of an MR4.0 and MR4.5 was collected
Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR.
时间窗: 24 months
Proportion of European Treatment and Outcome Study for CML (EUTOS)-qualified laboratories that perform qRT-PCR was documented
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy
时间窗: 24 months
Proportion of patients who discontinue Tyrosine kinase inhibitor (TKI) therapy was documented
次要结局
未报告次要终点