Clinical trial · Observational
Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
A Retrospective Observational Research Study to Describe the Real World Use of Bosutinib in a Single Centre in Scotland
NCT05363488CI-TRIAL-00116134completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bosutinib | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Chronic Myeloid Leukaemia
- description
- Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
- interventionNames
- Drug: Bosutinib
Primary outcomes (3)
- measure
- Cumulative response rate in partial and complete haematological response (PHR/CHR)
- timeFrame
- 16 May 2019 through 30 Nov 2019
- measure
- Cumulative response rate for partial and complete cytogenetic outcomes (PCyR/CCyR)
- timeFrame
- 16 May 2019 through 30 Nov 2019
- measure
- Cumulative response rate for molecular response (MR) outcome
- timeFrame
- 16 May 2019 through 30 Nov 2019
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.