NCT05166135

Latin American Real-world Study in Acute Leukemia

Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 589 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.

Detailed description

This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoid Leukemia

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2021-12-21
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

14 sites across 4 countries: Argentina, Brazil, Chile, Colombia