"Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia (CLL): Argentinian Experience"

CompletadoClinicalTrials.gov

ID: NCT04016636Tipo: OBSERVATIONALInicio: 12 de ago de 2019Fin estimado: 15 de oct de 2022

Traducción no disponible, mostrando original

Resumen

The aim of this study is to evaluate the impact of Ibrutinib monotherapy in the QoL of subjects with Chronic Lymphocytic Leukemia (CLL) based in European Quality of Life 5 Dimensions (EQ-5D) and FACIT- fatigue questionnaires assessment from baseline to 1 year of treatment in Argentinian routine clinical practice.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Written informed consent obtained prior to any screening procedure
Patients 18 years or older, to be treated with Ibrutinib, able to answer the complete QoL questionnaires.
Diagnosis of CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, with pathology confirmation (World Health Organization 2008).
Patients with CLL in first-line or with prior therapies or treatment-naïve patients that harbours deletion 17p according to fluorescence in situ hybridization (FISH) standards with an indication of treatment with ibrutinib.

Criterios de exclusión

Pregnant and breast-feeding patients
Impairment of ingestion and/or absorption of ibrutinib
Mental or physical limitation to complete the QoL questionnaires.

Intervenciones

other

Standard of Care

Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 12 months.

Ubicaciones

Fundaleu

Buenos Aires, Argentina

Patrocinadores

PrincipalMela Osorio Maria Jose

ColaboradorJanssen-Cilag Ltd.

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

"Impact of Ibrutinib on the Quality of Life (QOL) in Pati... | EligiMed