A Study to Evaluate Available Treatment Information of Ponatinib, Bosutinib, Imatinib, Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia
- Conditions
- Leukemia
- Interventions
- Other: No Intervention
- Registration Number
- NCT05743465
- Lead Sponsor
- Takeda
- Brief 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. No new data will be collected from participants as part of this study and no study medicines will be provided in this study.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1769
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ponatinib Cohort No Intervention 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. Bosutinib Cohort No Intervention 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. Other TKI Cohort No Intervention 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.
- Primary Outcome Measures
Name Time Method Quan-Charlson Comorbidity Index Score 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 Participants with Bone Marrow Stem Cell Transplant 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 Disease Severity Up to 6 months prior to the day of initiation of TKI drug i.e., Day 1 Number of Chronic Myeloid Leukemia (CML) Participants Categorized by Sociodemographic Variables at Diagnosis 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 Comorbidities 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 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 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.
Clinical Characteristics Assessed by Number of Participants With Major Adverse Cardiac Events (MACE), Arterial Occlusive Events (AOEs), and Venous Thrombotic Events (VTEs) 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).
Duration Between Last TKI Run-out Date to the Index Date for Participants with CML 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.
Treatment Patterns Based on Duration of Index Treatment 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.
- Secondary Outcome Measures
Name Time Method Percentage of CML Participants With Complications Up to approximately 5 years Progression Free Survival (PFS) Up to approximately 5 years PFS is defined as the time in days from the index date to the first observed disease progression.
Number of Participants With BCR-ABL and Bone Marrow Testing Up to approximately 5 years BCR-ABL test will include participants tested for BCR-ABL mutation, such as T315I, and participants with a diagnostic marrow test.
Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21 Up to approximately 5 years The disease severity will include categories of low, moderate, and high severity.
Number of Participants With CML With Treatment-Free Gap of the Index Treatment Up to approximately 5 years Treatment Patterns Based on Number of Participants With CML on Concomitant Medication Up to approximately 5 years The concomitant medications will include antithrombotic agents (anticoagulants, antiplatelet), antihypertensive, and antidiabetic drugs.
Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML Up to approximately 5 years 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.
Overall Survival (OS) Up to approximately 5 years 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.
Disease Progression Up to approximately 5 years 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.
Number of Participants with Atleast one Adverse Event, Major Adverse Cardiac Event (MACE), Arterial Occlusive Events (AOEs) and Venous Thrombotic Events (VTEs) Up to approximately 5 years 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.
Trial Locations
- Locations (1)
Takeda
🇺🇸Cambridge, Massachusetts, United States