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

CompletadoClinicalTrials.gov

ID: NCT05166135Tipo: OBSERVATIONALInicio: 10 de dic de 2021Fin estimado: 15 de nov de 2022

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Ubicaciones

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

FUNDALEU - Fundacion para combatir la Leucemia

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Patrocinadores

PrincipalPfizer

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