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

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.

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.

Inclusion Criteria:

• Patients ≥18 years old at diagnosis
• Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019
• At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period

Exclusion Criteria:

• Patients with no medical chart available
• Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data)
• Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment
• Patients with secondary AML
• Patients with any concomitant primary malignancy
• Patients with acute promyelocytic leukemia (APL)