A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT04016636
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2019-08-12
2022-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Impairment of ingestion and/or absorption of ibrutinib
* Mental or physical limitation to complete the QoL questionnaires.
18 Years
ALL
No
Sponsors
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Janssen-Cilag Ltd.
INDUSTRY
Mela Osorio Maria Jose
OTHER
Responsible Party
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Mela Osorio Maria Jose
Principal Investigator
Principal Investigators
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Maria Jose Mela, MD
Role: PRINCIPAL_INVESTIGATOR
Fundaleu
Miguel A Pavlovsky, MD
Role: STUDY_DIRECTOR
Fundaleu
Locations
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Fundaleu
Buenos Aires, , Argentina
Countries
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Other Identifiers
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QOL-Fundaleu0819
Identifier Type: -
Identifier Source: org_study_id
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