NCT05476562

Study Conducted Among Patients With CML

Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients With Chronic Myeloid Leukemia in Later Lines of Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,234 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Retrospective, non-interventional observational cohort study conducted among patients with CML.

Detailed description

A retrospective, non-interventional cohort study was used to address the study objectives. A cohort of adult patients with CML who were treated with TKIs were identified using the IBM® MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan database) to have a better understanding of real-world treatment patterns, HRU and healthcare costs among patients with CML treated with later lines of therapy (i.e., third line or later). For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental Databases were used (commercial claims). The commercial claims covered the period from 01/01/2001 to 06/30/2019. The study consisted of the following periods: * The baseline period was defined as the 6-month period before the first line therapy initiation for CML. * The observation period was defined as the period of at least 12 months from the first CML diagnosis to the end of data availability or end of health plan coverage, whichever occurs first; the observation period varied by patient.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
OTHER	Tyrosine Kinase Inhibitors (TKIs)	The study included patients with CML who were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs on third or later lines of therapy in the US.

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2022-07-27
• Last updated: 2022-11-08

Locations

1 site across 1 country: United States