REALITY-WW
Research type
Research Study
Full title
Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First- Line Treatment in Patients with Chronic Lymphocytic Leukemia in a Real-World Setting
IRAS ID
337519
Contact name
Oliver Miles
Contact email
Sponsor organisation
Janssen-Cilag, S.A.
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 9 months, 30 days
Research summary
REALITY is an international, multi-center, prospective observational cohort study to describe the management of previously untreated patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) using I+V treatment in a real-world setting. The main aim of this study is to collect information to understand the usage, factors which influence treatment decision by the treating doctor, how effective the treatment is and clinical response of I+V treatment in routine clinical practice. It is an observational study, meaning that patients will follow their routine clinical practice without any additional tests being performed beyond standard of care. The study is sponsored by Janssen Research and Development. Participating sites will be hospitals and other medical institutions treating and managing patients with CLL/SLL using I+V treatment within routine clinical practice. It will be conducted in the UK, Brazil, France, Israel and Italy.
Participants will be adult patients with a confirmed diagnosis of CLL/SLL requiring first-line treatment, using I+V treatment in routine clinical practice. The overall duration of the study will be approximately 4 years, with approximately 1.5 years enrollment, up to 15 cycles of I+V treatment, as per standard of care and up to approximately 1 year of follow-up. Approximately 200 patients will be included in the study globally. The primary data source for this study will be the medical records of each participating patient.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
24/PR/0211
Date of REC Opinion
21 May 2024
REC opinion
Further Information Favourable Opinion