Latin American Real-world Study in Acute Leukemia (LOYAL)

Pfizer

Status: Completed

Conditions: Acute Lymphoid Leukemia; Acute Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT05166135

X9001302

LOYAL (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 589 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

589 participants in 2 patient groups

Acute Myeloid Leukemia

Description:

Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period.

Relapsed/Refractory Acute Lymphoid Leukemia

Description:

Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period.