NCT05363488已完成不适用
A Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)
研究概览
简要总结
This study will describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia (CML) used in a real world clinical practice setting.
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
- •Patients with a diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
- •Patients prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27 March 2013) by the EMA OR via the compassionate use programme prior to marketing authorization.
- •Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients prescribed bosutinib as part of an interventional clinical trial programme.
- •Patients initiated on bosutinib less than 3 months prior to data collection taking place.
- •Patients prescribed bosutinib as exclusively post-allograft therapy.
研究组 & 干预措施
Chronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
干预措施: Bosutinib (Drug)
结局指标
主要结局
Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)
时间窗: 16 May 2019 through 30 Nov 2019
Cumulative response rate in partial and complete haematological response (PHR/CHR)
时间窗: 16 May 2019 through 30 Nov 2019
Cumulative response rate for molecular response (MR) outcome
时间窗: 16 May 2019 through 30 Nov 2019
次要结局
- Proportion of patients with an increase or reduction in dose(16 May 2019 through 30 Nov 2019)
- Proportion of patients who temporarily discontinued treatment(16 May 2019 through 30 Nov 2019)
- The proportion of patients converting to AP/BC(16 May 2019 through 30 Nov 2019)
- Rate of cross-intolerance between bosutinib and previously prescribed tyrosine kinase inhibitors (TKIs)(16 May 2019 through 30 Nov 2019)
- Proportion of patients who permanently discontinued(16 May 2019 through 30 Nov 2019)
- Proportion of patients with Philadelphia chromosome positive (Ph+) CML in chronic phase (CP), accelerated phase (AP) or blast crisis (BC) presenting with adverse events (AEs) considered related to bosutinib(16 May 2019 through 30 Nov 2019)
- Mean and relative dose intensity(16 May 2019 through 30 Nov 2019)
- Duration of treatment(16 May 2019 through 30 Nov 2019)
- Progression-free survival(From initiation of bosutinib to 1 year, 2 year, and 3 year)
- Proportion of patients who permanently discontinued treatment with bosutinib following an AE considered as related to bosutinib(16 May 2019 through 30 Nov 2019)
- Mean dosage prescribed at time of initiation and mean dosage during treatment(16 May 2019 through 30 Nov 2019)
- Describe the reason for selection of bosutinib in second line CML setting(16 May 2019 through November 2019)
- Overall survival(From initiation of bosutinib treatment to date of death up to 30 Nov 2019)
- Describe the reason for selection of bosutinib in second line CML setting(16 May 2019 through 30 Nov 2019)
研究者
研究点 (2)
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