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

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

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.

Study Overview

• Status: Completed
• Conditions: CLL
• Intervention / Treatment: Other: Standard of Care

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1114
    • Fundaleu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study includes patients with diagnosis of CLL with prescribed ibrutinib monotherapy as first-line or with prior therapies before or on the enrollment day as per routine clinical practice.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mela Osorio Maria Jose
• Collaborators: Janssen-Cilag Ltd.
• Investigators: Principal Investigator: Maria Jose Mela, MD, Fundaleu; Study Director: Miguel A Pavlovsky, MD, Fundaleu

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: QOL-Fundaleu0819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No