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

Study Overview
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Brief Summary
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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.

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

Conditions
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CLL

Intervention / Treatment
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* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Group Study. Patients with CLL receiving ibrutinib.<br>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. | Other: Standard of Care<br>* Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline | The FACIT (Functional Assessment of Chronic Illness Therapy) fatigue scale is a self-assessment questionnaire with a 7-day recall period and 13 items evaluating fatigue and its impact on daily life activities. Fatigue is scored 0-52. 0= severe fatigue; 52= no fatigue. Number of patients with an improvement of at least 3 points in FACIT score (Minimally Important Difference). This study is assessing a Change from Baseline Fatigue at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L) | The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Number of patients with improvements in the EQ5D domains by analyzing the variation in each domain and index during follow-up at different time points. | At 0,1,3,6,12 months |