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

NCT04016636 | Completed DMC

• 1 other identifier: QOL-Fundaleu0819
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

CLL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Number of patients with Clinically Significant Change in hemoglobin

  At 0,1,3,6,12 months

Study Arms (1)

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

Interventions

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.

Single Group Study. Patients with CLL receiving ibrutinib.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant and breast-feeding patients
• Impairment of ingestion and/or absorption of ibrutinib
• Mental or physical limitation to complete the QoL questionnaires.

Sponsors & Collaborators

• Mela Osorio Maria Jose: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Fundaleu

Buenos Aires, 1114, Argentina

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maria Jose Mela, MD

  Fundaleu

  PRINCIPAL INVESTIGATOR

• Miguel A Pavlovsky, MD

  Fundaleu

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: August 12, 2019
• Primary Completion: August 30, 2021
• Study Completion: October 15, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

AR (1)