A Non-Interventional Study of Bosutinib in Patients With Previously Treated Chronic Phase Chronic Myelogenous Leukemia (CML)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  This Non-Interventional Study (NIS) will aim to capture real-world treatment related adverse events (AEs) and discontinuation rates and evaluate effective dosing strategies employed in clinical practice when managing these AEs.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Non-Interventional

Study drug and medical condition

• Name of medicine:
  BOSULIF
• Medical condition to be studied:
  Chronic myeloid leukaemia

Population studied

• Short description of the study population:
  Previously treated patients from US with chronic phase chronic myelogenous leukemia (CML) who were prescribed or started with bosutinib.; Patients meeting the following criteria were included:; 1. 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; 2. Age 18 years or older; 3. Philadelphia chromosome positive or BCR-ABL positive CP ML; 4. Resistant or intolerant to previous therapy for CP CML; 5. Has been prescribed bosutinib for the treatment of previously treated CP CML, who has either not started treatment or has not taken bosutinib for more than 7 days at the time of baseline visit; 6. Prior history of malignancy is permitted
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  170

Study design details

• Main study objective:
  This Non-Interventional Study (NIS) will aim to capture real-world treatment related adverse events (AEs) and discontinuation rates and evaluate effective dosing strategies employed in clinical practice when managing these AEs.
• Outcomes:
  The primary objectives of this NIS are to:1. Determine the rate of treatment related AEs in CP CML patients treated with bosutinib.2. Observe the discontinuation (DC) rate due to treatment related AEs and compare with theDC rate in patients with chronic phase CML resistant or intolerant to previous treatment(s)observed in the clinical trials. Safetydosing, treatment duration, adherence, reasons for dose reductions/ delay/ discontinuations,timing and tests performed during treatment, concomitant medications).Patient self reported adherence information and quality of lifeResponses (results of hematological, cytogenetic and/or molecular testing)Baseline information to describe the patient population treated with bosutinib
• Data analysis plan:
  Analysis will be based on the safety population, which includes all enrolled patients whoreceived at least one dose of bosutinib. Patients who signed informed consent but who werenot treated will be reported with a reason(s) why treatment was not received.Analysis will be based on observed data. Incomplete dates will be imputed and details willbe included in the SAP.