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Completed

NCT Number: NCT04016636

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

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.

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Key information

Conditions

CLL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundaleu

Buenos Aires, 1114, Argentina

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care

Other

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

Primary outcomes

  1. Change From Baseline

    Time frame: 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 outcomes

  1. Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)

    Time frame: 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 outcomes

  1. Number of patients with Clinically Significant Change in hemoglobin

    Time frame: At 0,1,3,6,12 months

    Number of Participants with Clinically Significant Change in hemoglobin will be determined

Sponsors and collaborators

Lead sponsor

Mela Osorio Maria Jose

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 11, 2019
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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