A RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 87
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)
研究概览
简要总结
The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
- •Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 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
- •Prescribed bosutinib as part of an interventional clinical trial programme.
- •Initiated on bosutinib less than 3 months prior to data collection taking place.
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
Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)
时间窗: Baseline up to 5.5 years
Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei.
Percentage of Participants With Cumulative Complete Haematological Response (CHR)
时间窗: Baseline up to 5.5 years
Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (\<) 450\*10\^9 per liter, white blood cells count \<10\*10\^9 per liter, no immature granulocytes and \<5 percent (%) basophils on differential and a non-palpable spleen.
Percentage of Participants With Cumulative Partial Haematological Response (PHR)
时间窗: Baseline up to 5.5 years
Haematological response used blood sample of the participants to evaluate response to treatment for CML.
Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)
时间窗: Baseline up to 5.5 years
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (\<=) 0.1% on the IS.
Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)
时间窗: Baseline up to 5.5 years
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases.
Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)
时间窗: Baseline up to 5.5 years
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases.
Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)
时间窗: Baseline up to 5.5 years
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases.
Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)
时间窗: Baseline up to 5.5 years
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with \<0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (\>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.
Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)
时间窗: Baseline up to 5.5 years
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with \<0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with \>32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.
次要结局
- Overall Survival (OS)(From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3)
- Percentage of Participants With Disease Progression(Year 1, 2, 3)
- Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3(Baseline up to 5.5 years)
- Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy(Baseline up to 5.5 years)
- Cross-Intolerance Between Bosutinib and Previous Therapy(Baseline up to 5.5 years)
- Mean Dose of Bosutinib at Initiation of Treatment(Baseline up to 5.5 years)
- Relative Bosutinib Dose Intensity(Baseline up to 5.5 years)
- Duration of Bosutinib Therapy(Baseline up to 5.5 years)
- Percentage of Participants With Treatment Related Adverse Events (AEs)(Baseline up to 5.5 years)
- Progression-free Survival (PFS)(Year 1, 2, 3)