Clinical trial · Observational
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
A RETROSPECTIVE OBSERVATIONAL RESEARCH STUDY TO DESCRIBE THE REAL WORLD USE OF BOSUTINIB IN THE UK AND NETHERLANDS
NCT02546375CI-TRIAL-00070135completedResults postedClinicalTrials.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)
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
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 |
|---|---|---|---|
| Chronic Myeloid Leukaemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
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 (9)
- measure
- Percentage of Participants With Cumulative Complete Haematological Response (CHR)
- timeFrame
- Baseline up to 5.5 years
- description
- 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.
- measure
- Percentage of Participants With Cumulative Partial Haematological Response (PHR)
- timeFrame
- Baseline up to 5.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Prescribed bosutinib as part of an interventional clinical trial programme. * Initiated on bosutinib less than 3 months prior to data collection taking place.
References
Publications (0)
Data not yet available
No reference posted for this study.