Myeloid Leukemia, ChronicNCT07150793
A Study of Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan
An observational study of Myeloid Leukemia, Chronic, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan. This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Myeloid Leukemia, Chronic
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 8 Feb 2023
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, non-interventional cohort study.
Who may be able to join
- Patients who had at least one TKI prescription during the selection period,
- a confirmed diagnosis of chronic phase CML recorded before or at the index date,
- were aged 15 years or older at the index date, and
- had at least 12-months continuous pre-index period.
Who cannot join
- Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment [LoT]),
- a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date,
- a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date,
- a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date,
- a stem cell transplant procedure recorded during the pre-index period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan - A Retrospective Claims Database Analysis
The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.
This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.
- Conditions
- Myeloid Leukemia, Chronic
- Keywords
- Tyrosine Kinase Inhibitor, Real-world
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CML Cohort | Patients diagnosed with chronic phase CML who received treatment with a TKI in Japan between 01 January 2011 and 31 December 2019. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Line of Treatment (LoT) and TKI Received
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
Number of Patients who Switched TKI Treatment by LoT and TKI
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
Number of Patients who Discontinued TKI Treatment by Type of TKI
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
TKI Dose by LoT
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Baseline, up to approximately 9 years
TKI Persistence Rate by LoT
Measured: Months 6, 12, 18, and Year 5
Duration of TKI Treatment by LoT
Measured: Up to approximately 9 years
Secondary outcomes (5)
Annual Incidence of Inpatient and Outpatient Visits by LoT
Measured: Up to approximately 9 years
Annual Mean Cost of All-cause Healthcare Resource Use by LoT
All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN):
- Total costs
- Inpatient costs
- Outpatient costs
- Pharmacy costs
Measured: Up to approximately 9 years
Annual Incidence of CML-related Healthcare Resource Use by LoT
CML-related care included:
- Major BCR-ABL1 procedures (diagnostic and response to treatment testing)
- Complete blood count testing - peripheral blood general testing
- Hematological examination diagnosis fee
- TKI prescriptions
Measured: Up to approximately 9 years
Annual Mean Cost of CML-related Healthcare Resource Use by LoT
CML-related care costs were calculated in Japanese Yen (JPY) and included the following:
- Total CML-related costs
- Major BCR-ABL1 procedure costs
- Complete blood count testing - peripheral blood general testing costs
- Hematological examination costs
- TKI prescription costs
Measured: Up to approximately 9 years
Number of Patients With Adverse Events by TKI
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Measured: Up to approximately 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start5 Jul 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid Leukemia, ChronicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150793
- Sponsor's protocol ID
- CAMN107AJP11
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Treatment and Burden of Chronic Myeloid Leukemia Patients in Japan - A Retrospective Claims Database Analysis
- ClinicalTrials.gov ID
- NCT07150793
- Acronym / sponsor ID
- CAMN107AJP11
- Conditions
- Myeloid Leukemia, Chronic
- Keywords
- Tyrosine Kinase Inhibitor, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 2 Sep 2025 (actual)
- 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 main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan.
This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML Cohort | – | –Patients diagnosed with chronic phase CML who received treatment with a TKI in Japan between 01 January 2011 and 31 December 2019. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (4 listed)
- Patients who had at least one TKI prescription during the selection period,
- a confirmed diagnosis of chronic phase CML recorded before or at the index date,
- were aged 15 years or older at the index date, and
- had at least 12-months continuous pre-index period.
Key exclusion criteria (5 listed)
- Patients who had at least one TKI prescription in the 12 months preceding the index date (washout period to catch the 1st line of treatment [LoT]),
- a confirmed diagnosis of CML blast crisis or accelerated phase recorded prior to, at, or within 6 months after the index date,
- a confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) within 6 months after the index date,
- a medical record of chemotherapy (not including hydroxyurea) within 6 months after the index date,
- a stem cell transplant procedure recorded during the pre-index period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients by Line of Treatment (LoT) and TKI Received
Time frame: Up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Number of Patients who Switched TKI Treatment by LoT and TKI
Time frame: Up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Number of Patients who Discontinued TKI Treatment by Type of TKI
Time frame: Up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI
Time frame: Up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI
Time frame: Up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
TKI Dose by LoT
Time frame: Baseline, up to approximately 9 years
TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib.
TKI Persistence Rate by LoT
Time frame: Months 6, 12, 18, and Year 5
Duration of TKI Treatment by LoT
Time frame: Up to approximately 9 years
5 secondary outcomes
Annual Incidence of Inpatient and Outpatient Visits by LoT
Time frame: Up to approximately 9 years
Annual Mean Cost of All-cause Healthcare Resource Use by LoT
Time frame: Up to approximately 9 years
Annual Incidence of CML-related Healthcare Resource Use by LoT
Time frame: Up to approximately 9 years
Annual Mean Cost of CML-related Healthcare Resource Use by LoT
Time frame: Up to approximately 9 years
Number of Patients With Adverse Events by TKI
Time frame: Up to approximately 9 years
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 2 Sep 2025.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloid Leukemia, Chronic, run by Novartis Pharmaceuticals at 1 site in United States.
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 4 inclusion and 5 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of Patients by Line of Treatment (LoT) and TKI Received (time frame: Up to approximately 9 years). The study lists 8 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 2 Sep 2025.