N/A
Completed N=87
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
Source: ClinicalTrials.gov NCT02546375 ↗Enrolled (actual)
87
Serious AEs
19.5%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants With Cumulative Complete Haematological Response (CHR) — 93 percentage of participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cumulative Complete Haematological Response (CHR) |
93 | — |
| PRIMARY Percentage of Participants With Cumulative Partial Haematological Response (PHR) |
94 | — |
| PRIMARY Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) |
67 | — |
| PRIMARY Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) |
77 | — |
| PRIMARY Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) |
80 | — |
| PRIMARY Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) |
77 | — |
| PRIMARY Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) |
33 | — |
| PRIMARY Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) |
27 | — |
| PRIMARY Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) |
55 | — |
| SECONDARY Percentage of Participants With Treatment Related Adverse Events (AEs) |
94 | — |
| SECONDARY Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 |
21 | — |
| SECONDARY Progression-free Survival (PFS) |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Percentage of Participants With Disease Progression |
3; 3; 0 | — |
| SECONDARY Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy |
14; 5; 11; 2; 2; 1 | — |
| SECONDARY Cross-Intolerance Between Bosutinib and Previous Therapy |
1.1 | — |
| SECONDARY Mean Dose of Bosutinib at Initiation of Treatment |
331.0 | — |
| SECONDARY Relative Bosutinib Dose Intensity |
66 | — |
| SECONDARY Duration of Bosutinib Therapy |
15.6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02546375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.