Status:
COMPLETED
A Study to Evaluate Impact of Ibrutinib on the Quality of Life (QOL) in Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Mela Osorio Maria Jose
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
CLL
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- Pregnant and breast-feeding patients
- Impairment of ingestion and/or absorption of ibrutinib
- Mental or physical limitation to complete the QoL questionnaires.
Key Trial Info
Start Date :
August 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04016636
Start Date
August 12 2019
End Date
October 15 2022
Last Update
February 16 2023
Active Locations (1)
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1
Fundaleu
Buenos Aires, Argentina, 1114