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

NCT05743465 | Completed FDA Drug

• 1 other identifier: GOR-2017-102256
• Study Type: observational
• Target: 1,769
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline (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

• 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.

  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).

  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).

  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.

  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.

  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

  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).

  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.

  Up to approximately 5 years

Secondary Outcomes (10)

• Number of Participants With BCR-ABL and Bone Marrow Testing

  Up to approximately 5 years

• Treatment Patterns Based on Mean Starting Daily Dose and Average Daily Dose in Participants with CML

  Up to approximately 5 years

• Number of CML Participants With Disease Severity as per Medstat Disease Staging Clinical Criteria Version 5.21

  Up to approximately 5 years

• Treatment Patterns Based on Number of Participants With CML on Concomitant Medication

  Up to approximately 5 years

• Number of Participants With CML With Treatment-Free Gap of the Index Treatment

  Up to approximately 5 years

Study Arms (3)

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.

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.

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.

Other: No Intervention

Interventions

No Intervention OTHER

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

Bosutinib Cohort; Other TKI Cohort; Ponatinib Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda

Cambridge, Massachusetts, 02139, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: October 6, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)