A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia

An observational study of Leukemia, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant's condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Leukemia
How many people: 1,769 participants
Where: 1 siteUnited States
Study dates: 6 Oct 2021to 30 Nov 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with a diagnosis of CP-CML and who had ≥1 prescription for TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from April 1, 2013-March 31, 2017 will be included in this study.

Who may be able to join

Participants will be included in the study if they:
had ≥1 prescription for TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from April 1, 2013-March 31, 2017;
For participants with ponatinib use, the first ponatinib prescription date will be defined as the index date; for participants with bosutinib but not ponatinib use, the first bosutinib prescription date will be defined as the index date; and for participants without ponatinib and bosutinib use, the first imatinib, dasatinib, nilotinib prescription date will be defined as the index date.
Participants with >1 type of TKI on the index date will be dropped.
had ≥1 medical diagnosis for CML (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 205.1; ICD-10-CM: C92.1) any time prior to the index date or within 6 months post-index date; diagnosis codes in the primary or secondary position will be used; the first CML diagnosis date will be designated as the initial CML diagnosis date;
were aged ≥18 years on the index date;

Show all 9Show fewer

were active in the Humedica EMR data 6 months pre- and post-index date, indicated by the first and last healthcare activity in the data;
Participant data will be assessed until the earliest of switch to another TKI, disenrollment, death, or study end date. The minimum required duration of follow-up can be further revised based on the average duration of first-line treatment.
Participants who died in 6 months will be included.

Who cannot join

Participants will be excluded from the study if they:
had ≥1 prescription for their index TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) any time prior to the index date.
This will allow ≥6-month wash-out period, and ensure we are capturing second line participants.

Trial locations and contacts

1 site in 1 country.

United States1 site

Takeda
Cambridge, Massachusetts, 02139

Other trials in United States

About this study

Official title: Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors Among Chronic Myeloid Leukemia Patients

Read the detailed description

This is a retrospective cohort analysis study in participants with chronic phase chronic myeloid leukemia (CP-CML). This study will use Humedica electronic medical record (EMR) data to evaluate the real-world treatment patterns, safety, and efficacy of ponatinib and other tyrosine kinase inhibitors (TKIs) among CP-CML participants.

The study will enroll approximately 1769 patients. Based on the TKI drug used on index date, stratified by prior TKI use, participants will be classified into the following cohorts -

Ponatinib Cohort
Bosutinib Cohort
Other TKI Cohort

This is a multicenter study conducted in the United States (US). The overall duration for data collection in this trial will be approximately 5 years.

Conditions: Leukemia
Being tested: No Intervention
Keywords: Drug Therapy
Medical subject headings: Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No InterventionOther
As this is an observational study, no intervention will be administered in this study.

Study groups in NCT05743465
Study group	Role	What they receive
Ponatinib Cohort		Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants with a ponatinib prescription identified as the index drug prior TKI use will be stratified in this cohort. Receives: Other: No Intervention
Bosutinib Cohort		Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants without ponatinib use and with bosutinib identified as the index drug prior TKI use will be stratified in this cohort. Receives: Other: No Intervention
Other TKI Cohort		Participants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants without ponatinib or bosutinib use and with imatinib, dasatinib, or nilotinib identified as the index drug after prior TKI use will be stratified in this cohort. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis
Socio-demographic variables included will include categories of Age (in years), Sex (male and female), and US geographic region.
Measured: Baseline (Day 1)
Number of CML Participants With Baseline Clinical Characteristics of Disease Severity
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Quan-Charlson Comorbidity Index Score
The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity.
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of CML Participants With Baseline Clinical Characteristics of Comorbidities
Comorbidities will include anemia, diabetes, chronic pulmonary disease, congestive heart failure, hypertension, hypercholesterolemia, obesity, renal disease, moderate to severe liver disease, dementia, acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV).
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of CML Participants With Baseline Clinical Characteristics of Concomitant Medication
Concomitant medication will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta blockers and statins) and antidiabetic drugs (metformin, sulfonylurea, thiazolidinedione, insulin and other antidiabetic drugs).
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of Previous Treatments of Tyrosine Kinase Inhibitors (TKI) Drugs in Participants with CML
The number of TKI drugs used prior to the index date will be identified. The type of the 1^st and 2^nd TKI drugs will be identified.
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Duration Between Last TKI Run-out Date to the Index Date for Participants with CML
Time from the run-out date of the last prescription to the index date will be calculated. If the run-out date passed the index date, the gap will be counted as 0.
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Number of Participants with Bone Marrow Stem Cell Transplant
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs)
MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as pulmonary embolism (PE) and deep vein thrombosis (DVT).
Measured: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Treatment Patterns Based on Duration of Index Treatment
Time from the first prescription of the index drug to the run-out date of the last prescription of the index drug, or 1 day before a new TKI prescription date, whichever occurred earlier.
Measured: Up to approximately 5 years

Secondary outcomes (10)

Number of Participants With BCR-ABL and Bone Marrow Testing
BCR-ABL test will include participants tested for BCR-ABL mutation, such as T315I, and participants with a diagnostic marrow test.
Measured: Up to approximately 5 years
Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML
The mean daily and average dose of the first prescription in the treatment line will be calculated. The starting and average daily dose will be classified as low, standard, and high for each drug cohort.
Measured: Up to approximately 5 years
Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21
The disease severity will include categories of low, moderate, and high severity.
Measured: Up to approximately 5 years
Treatment Patterns Based on Number of Participants With CML on Concomitant Medication
The concomitant medications will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs.
Measured: Up to approximately 5 years
Number of Participants With CML With Treatment-Free Gap of the Index Treatment
Measured: Up to approximately 5 years
Disease Progression
Disease progression will be defined as having a change of disease severity from low severity in the baseline period to moderate or high severity in the current line, or from moderate severity in the baseline period to high severity in the current line OR a change in TKI type, addition of chemotherapy agents, or allogeneic stem cell transplant procedure OR mortality.
Measured: Up to approximately 5 years
Percentage of CML Participants With Complications
Measured: Up to approximately 5 years
Overall Survival (OS)
OS is defined as the interval between the first does of study treatment and death due to any cause, censored at the last contact date when the participant was alive.
Measured: Up to approximately 5 years
Progression Free Survival (PFS)
PFS is defined as the time in days from the index date to the first observed disease progression.
Measured: Up to approximately 5 years
Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs)
AE is any untoward medical occurrence in participant administered medicinal investigational drug. Untoward medical occurrence does not necessarily have to have causal relationship with the treatment. MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as PE and DVT.
Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 202130 Nov 2022

First posted24 Feb 2023
Study start6 Oct 2021
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for LeukemiaStudies of the same condition, open and under way.
More trials run by TakedaThe 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: 1,769 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05743465
Sponsor's protocol ID: GOR-2017-102256
Status last verified: Feb 2023
First submitted: 14 Feb 2023
Last updated: 2 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors Among Chronic Myeloid Leukemia Patients
ClinicalTrials.gov ID: NCT05743465
Acronym / sponsor ID: GOR-2017-102256
Conditions: Leukemia
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,769 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 6 Oct 2021 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 24 Feb 2023 (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.

Detailed description

The study will enroll approximately 1769 patients. Based on the TKI drug used on index date, stratified by prior TKI use, participants will be classified into the following cohorts -

Ponatinib Cohort
Bosutinib Cohort
Other TKI Cohort

This is a multicenter study conducted in the United States (US). The overall duration for data collection in this trial will be approximately 5 years.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Ponatinib Cohort	–	Other: No InterventionParticipants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants with a ponatinib prescription identified as the index drug prior TKI use will be stratified in this cohort.
Bosutinib Cohort	–	Other: No InterventionParticipants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants without ponatinib use and with bosutinib identified as the index drug prior TKI use will be stratified in this cohort.
Other TKI Cohort	–	Other: No InterventionParticipants will be classified into the cohorts based on the TKI (ponatinib, bosutinib, and others [imatinib, dasatinib, or nilotinib]) drug used on index date, stratified by prior TKI use. Participants without ponatinib or bosutinib use and with imatinib, dasatinib, or nilotinib identified as the index drug after prior TKI use will be stratified in this cohort.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with a diagnosis of CP-CML and who had ≥1 prescription for TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from April 1, 2013-March 31, 2017 will be included in this study.

Key inclusion criteria (9 listed)

had ≥1 prescription for TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from April 1, 2013-March 31, 2017;
had ≥1 medical diagnosis for CML (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 205.1; ICD-10-CM: C92.1) any time prior to the index date or within 6 months post-index date; diagnosis codes in the primary or secondary position will be used; the first CML diagnosis date will be designated as the initial CML diagnosis date;
were aged ≥18 years on the index date;
were active in the Humedica EMR data 6 months pre- and post-index date, indicated by the first and last healthcare activity in the data;

Key exclusion criteria (3 listed)

had ≥1 prescription for their index TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) any time prior to the index date.
This will allow ≥6-month wash-out period, and ensure we are capturing second line participants.

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
No InterventionAs this is an observational study, no intervention will be administered in this study.	Other	Bosutinib Cohort, Other TKI Cohort, Ponatinib Cohort

Primary outcome

Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis
Time frame: Baseline (Day 1)
Socio-demographic variables included will include categories of Age (in years), Sex (male and female), and US geographic region.
Number of CML Participants With Baseline Clinical Characteristics of Disease Severity
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Quan-Charlson Comorbidity Index Score
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
The Charlson Comorbidity Index is a 19-item measure assessing comorbid conditions. The total possible score on the Charlson Comorbidity Index ranges from 0 to 37. If a condition is not present, the score for that condition is zero. The higher scores indicate greater comorbidity.
Number of CML Participants With Baseline Clinical Characteristics of Comorbidities
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Comorbidities will include anemia, diabetes, chronic pulmonary disease, congestive heart failure, hypertension, hypercholesterolemia, obesity, renal disease, moderate to severe liver disease, dementia, acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV).
Number of CML Participants With Baseline Clinical Characteristics of Concomitant Medication
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Concomitant medication will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs (angiotensin converting enzyme inhibitor, angiotensin receptor blocker, beta blockers and statins) and antidiabetic drugs (metformin, sulfonylurea, thiazolidinedione, insulin and other antidiabetic drugs).
Number of Previous Treatments of Tyrosine Kinase Inhibitors (TKI) Drugs in Participants with CML
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
The number of TKI drugs used prior to the index date will be identified. The type of the 1^st and 2^nd TKI drugs will be identified.
Duration Between Last TKI Run-out Date to the Index Date for Participants with CML
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Time from the run-out date of the last prescription to the index date will be calculated. If the run-out date passed the index date, the gap will be counted as 0.
Number of Participants with Bone Marrow Stem Cell Transplant
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs)
Time frame: Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1
MACE will be categorized as myocardial infarction and stroke. AOE will be categorized according to cardiovascular events, cerebrovascular events and peripheral vascular arterial events will be categorized as pulmonary embolism (PE) and deep vein thrombosis (DVT).
Treatment Patterns Based on Duration of Index Treatment
Time frame: Up to approximately 5 years
Time from the first prescription of the index drug to the run-out date of the last prescription of the index drug, or 1 day before a new TKI prescription date, whichever occurred earlier.

10 secondary outcomes

Number of Participants With BCR-ABL and Bone Marrow Testing
Time frame: Up to approximately 5 years
Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML
Time frame: Up to approximately 5 years
Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21
Time frame: Up to approximately 5 years
Treatment Patterns Based on Number of Participants With CML on Concomitant Medication
Time frame: Up to approximately 5 years
Number of Participants With CML With Treatment-Free Gap of the Index Treatment
Time frame: Up to approximately 5 years
Disease Progression
Time frame: Up to approximately 5 years
Percentage of CML Participants With Complications
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs)
Time frame: Up to approximately 5 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 Mar 2023.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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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.

Study Director study director

Takeda

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 Leukemia, run by Takeda 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 9 inclusion and 3 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 Mar 2023. 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 Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis (time frame: Baseline (Day 1)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743465.

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 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.