Trial · NCT02546375
A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
NCT02546375, Completed, Pfizer; results first posted 2018-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands. Trials, record NCT02546375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02546375
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands
- NCT number
- NCT02546375
- Status
- Completed
- Enrollment
- 87 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Chronic Myeloid Leukaemia
- Interventions
- Bosutinib
- First posted
- 2015-09-10
- Last updated
- 2023-10-03
- Results first posted
- 2018-09-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Baseline up to 5.5 years | 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. |
| Primary | Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Baseline up to 5.5 years | Haematological response used blood sample of the participants to evaluate response to treatment for CML. |
| Primary | Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Baseline up to 5.5 years | Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei. |
| Primary | Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases. |
| Primary | Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases. |
| Primary | Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases. |
| Primary | Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with \<0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (\>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. |
| Primary | Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with \<0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with \>32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. |
| Primary | Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (\<=) 0.1% on the IS. |
| Secondary | Percentage of Participants With Treatment Related Adverse Events (AEs) | Baseline up to 5.5 years | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Related Adverse Events (AEs) | Baseline up to 5.5 years | All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. | percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Bosutinib | 93 | percentage of participants | ||
| Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Bosutinib | 94 | percentage of participants | ||
| Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Bosutinib | 67 | percentage of participants | ||
| Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | Bosutinib | 77 | percentage of participants | ||
| Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | Bosutinib | 80 | percentage of participants | ||
| Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | Bosutinib | 77 | percentage of participants | ||
| Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Bosutinib | 33 | percentage of participants | ||
| Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Bosutinib | 27 | percentage of participants | ||
| Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Bosutinib | 55 | percentage of participants | ||
| Percentage of Participants With Treatment Related Adverse Events (AEs) | Bosutinib | 94 | percentage of participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosutinib | 87 | |
| Overall Study | COMPLETED | Bosutinib | 87 | |
| Overall Study | NOT COMPLETED | Bosutinib | 0 |
Source ClinicalTrials.gov
Adverse events103
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bosutinib | 3 | 87 | |
| other | Creatinine increased | Blood and lymphatic system disorders | Bosutinib | 5 | 87 | |
| other | Neutropenia | Blood and lymphatic system disorders | Bosutinib | 1 | 87 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bosutinib | 6 | 87 | |
| other | Atrial fibrillation | Cardiac disorders | Bosutinib | 3 | 87 | |
| other | Cardiac failure | Cardiac disorders | Bosutinib | 0 | 87 | |
| other | Hypertension | Cardiac disorders | Bosutinib | 1 | 87 | |
| other | Abdominal Distension | Gastrointestinal disorders | Bosutinib | 1 | 87 | |
| other | Abdominal pain | Gastrointestinal disorders | Bosutinib | 8 | 87 | |
| other | Constipation | Gastrointestinal disorders | Bosutinib | 1 | 87 |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosutinib | ||
| Total, other adverse events | Bosutinib | 81 | 87 |
| Total, serious adverse events | Bosutinib | 17 | 87 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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