NCT05743465

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,769 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	No Intervention	As this is an observational study, no intervention will be administered in this study.

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2023-02-24
• Last updated: 2023-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study