A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia

Mela Osorio Maria Jose

Status: Completed

Conditions: CLL

Treatments: Other: Standard of Care

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04016636

QOL-Fundaleu0819

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

50 participants in 1 patient group

Single Group Study. Patients with CLL receiving ibrutinib.

Description:

In this study the investigator does not assign specific interventions to the study participants. Participants will receive interventions as part of routine medical care, and the investigator will observe the effect of the intervention. This study will collect prospective real-world data to describe the quality of life (QOL) in patients with CLL receiving ibrutinib in routine Argentinian clinical practice over a 12-month follow-up period. The primary data source for this observational study will be the medical records of each enrolled patient, as well as questionnaires concerning quality of life. Data will be collected at baseline and on months 1,3,6 and 12 during a prospective period.

Treatment:

Other: Standard of Care