An observational study - Evaluation of efficacy and safety of Bosulif® under real life conditions of use (BOSEVAL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  Bosulif
• Study drug International non-proprietary name (INN) or common name:
  BOSUTINIB MONOHYDRATE
• Additional medical condition(s):
  Chronic Myeloid Leukemia (CML)

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Study design:
  Non-interventional observational multicentric prospective study not affecting the patient’s medical care.
• Main study objective:
  To determine the percentage of patients with Ph+ CML in chronic, accelerated or blast phase presenting with AEs considering related to bosutinib by the investigator,
• Outcomes:
  To evaluate the percentage of patients who permanently discontinued bosutinib following an AE considered as related to bosutinib by the investigator. ; - Safety profile of bosutinib ; - Evaluate patient compliance ; - Evaluate quality of life ; - Describe the methods of treatment of bosutinib under real-life conditions of use ; - Evaluate the efficacy of treatment ; - Describe the haematological, cytogenetic and molecular responses ; - Describe the characteristics of patients; - Evaluate cross-intolerance between bosutinib and previously prescribe TKI
• Data analysis plan:
  The descriptive analysis of qualitative and ordinal variables will consist of the sample size and frequency of each modality with its 95% confidence interval (CI), as well as the number of missing data. Quantitative variables will be described in terms of sample size, mean, median, standard deviation, confidence interval, as well as number of missing data. Data on overall survival and progression-free survival will be described with Kaplan Meier curves. Median survival will be estimated and presented with its 95% CI. The data will be evaluated separately for patients with Ph + CML in PC, PA or CB and depending on the processing line. Interim analyzes will be carried out once a year.

Documents

Study report

B1871047_BOSEVAL_Study report_V1.0_30MAY2024.pdf

B1871047_BOSEVAL_Study report abstract_V1.0_30MAY2024.pdf

2024-48327 CIOMS_1.pdf

2024-48327 CIOMS_2.pdf

2024-48327 CIOMS_3.pdf

2024-48327 CIOMS_4.pdf

2024-48327 CIOMS_5.pdf

2024-48327 CIOMS_6.pdf