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

NCT ID: NCT05743465

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1769 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2022-11-30

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.

Conditions

Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No Intervention

Intervention Type: OTHER

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

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.

No Intervention

Intervention Type: OTHER

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

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.

No Intervention

Intervention Type: OTHER

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

Interventions

No Intervention

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Takeda

Cambridge, Massachusetts, United States

Countries

United States

Related Links

https://clinicaltrials.takeda.com/study-detail/5a2b267658b5473c?idFilter=%5B%22GOR-2017-102256%22%5D

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

Other Identifiers

GOR-2017-102256

Identifier Type: -

Identifier Source: org_study_id