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

CLL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016636
• Other study ID #: QOL-Fundaleu0819
• Status: Completed
• Start date: August 12, 2019
• Est. completion date: October 15, 2022

Study information

• Verified date: February 2023
• Source: Fundaleu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2022
• Est. primary completion date: August 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CLL
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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.

Locations

Country	Name	City	State
Argentina	Fundaleu	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Mela Osorio Maria Jose	Janssen-Cilag Ltd.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with Clinically Significant Change in hemoglobin	Number of Participants with Clinically Significant Change in hemoglobin will be determined	At 0,1,3,6,12 months
Primary	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	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