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

Takeda1,769 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,769

Conditions

Leukemia

Interventions

No InterventionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: Participants will be included in the study if they: 1. 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. 2. 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; 3. were aged ≥18 years on the index date; 4. 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. Exclusion criteria: Participants will be excluded from the study if they: 1. had ≥1 prescription for their index TKI (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) any time prior to the index date. 2. This will allow ≥6-month wash-out period, and ensure we are capturing second line participants.

Locations (1)

Takeda

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Day 1)

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

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.

Time frame: 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).

Time frame: 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).

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

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.