Prospective Cohort Study With Fixed-Duration Ibrutinib + Venetoclax (I+V) First-Line Treatment in Patients with Chronic Lymphocytic Leukemia in a Real-World Setting (REALITY-WW)

Research summary

This is an international, multicenter, prospective observational cohort study to describe the management of previously untreated patients with CLL/SLL using I+V treatment in a real-world setting. Participants will be adult patients with a confirmed diagnosis of CLL/SLL requiring first-line treatment, per iwCLL 2018 criteria or at the discretion of the treating physician using I+V treatment in routine clinical practice. The decision to start I+V treatment must have been taken prior to and independently of the patient’s inclusion in the study. All aspects of treatment and clinical management of patients will be in accordance with routine clinical practice and applicable local regulations, at the sole discretion of the treating physician. Prior to data collection, all patients must sign an ICF/participation agreement allowing data collection and source data verification in accordance with local requirements. Only data available per clinical practice will be collected within this study. Additionally, where permitted in accordance with local regulations, participating physicians will be asked to obtain patient-reported outcome data from participating patients. No additional assessments or procedures are required per protocol. Study data collection will start at baseline, after signed informed consent and within 30 days before initiation of I+V treatment for the first participating patient. The end of the study will be the last documented data collection point within the study for the last participating patient. The overall duration of the study is expected to 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 this study.

Principal Investigator

Dr Danmei Xu

Contact us

Email: Latephasehaematology@ouh.nhs.uk

IRAS number

337519