CLL
Conditions
Brief summary
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.
Interventions
OTHERStandard 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.
Sponsors
Janssen-Cilag Ltd.
Mela Osorio Maria Jose
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L) | At 0,1,3,6,12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Clinically Significant Change in hemoglobin | At 0,1,3,6,12 months | Number of Participants with Clinically Significant Change in hemoglobin will be determined |
Countries
Argentina
Outcome results
None listed