Chronic Myelogenous LeukemiaBLFNCT02501330
Safety And Efficacy Of Bosutinib
An observational study of Chronic Myelogenous Leukemia, run by Pfizer.
Trial summary
The objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Bosutinib
- Type of treatment
- Pill or oral medicine
- How many people
- 702 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who have been treated with Bosutinib
Who may be able to join
- Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
- Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug
Who cannot join
- Patients with a history of hypersensitivity
- Women who may possibly be pregnant or become pregnant
About this study
Official title: DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
The objective of this surveillance is to collect information about
- adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
- the incidence of adverse drug reactions in this surveillance
- factors considered to affect the safety and/or efficacy of this drug.
Read the detailed description
The patients should be registered by central registration system.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Bosutinib
- Keywords
- Drug use investigation in Japan
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosutinibDrug
Also called BOSULIF
The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Bosutinib | Not described Receives: Drug: Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse drug reactions
Measured: 24 weeks
Cytogenetic response
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study start1 Jul 2015
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501330
- Sponsor's protocol ID
- B1871036
- Other IDs
- NCT02501330
- Acronym
- BLF
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2015
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)
- ClinicalTrials.gov ID
- NCT02501330
- Acronym / sponsor ID
- BLF / B1871036
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Drug use investigation in Japan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this surveillance is to collect information about
- adverse drug reaction not expected from the LPD (unknown adverse drug reaction)
- the incidence of adverse drug reactions in this surveillance
- factors considered to affect the safety and/or efficacy of this drug.
Detailed description
The patients should be registered by central registration system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosutinib | – | Drug: Bosutinib |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who have been treated with Bosutinib
Key inclusion criteria (2 listed)
- Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
- Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity
- Women who may possibly be pregnant or become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosutinibAlso: BOSULIFThe recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily. | Drug | Bosutinib |
Primary outcome
The incidence of adverse drug reactions
Time frame: 24 weeks
Cytogenetic response
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myelogenous Leukemia, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse drug reactions (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.