CLL CORE Study
Research type
Research Study
Full title
Chronic Lymphocytic Leukemia (CLL) Collaborative Study Of Real-World Evidence (CORE)
IRAS ID
274191
Contact name
Kavita Sail
Contact email
Sponsor organisation
AbbVie Inc.
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Chronic Lymphocytic Leukemia (CLL) is the most common type of leukemia (cancer of blood cells) in adults affecting men more so than women. The average age of diagnosis is 72. Many patients initially do not show any ill effects, so no treatment is required until symptoms develop. Chemotherapy, the standard treatment, is often poorly tolerated by the elderly due to side effects. With advent of novel therapies like small molecule inhibitors of B-Cell Receptor (BCRi) signaling, acalabrutinib, ibrutinib, idealalisib, and a small molecule BCL-2 inhibitor, venetoclax, evidence on real-world outcomes is emerging. The objective of CORE study is to collect data retrospectively through patient chart reviews from real-world clinical practice of patients with CLL/Small Lymphocytic Leukemia (SLL), and assess the objectives within the following areas of treatment: sequencing, effectiveness, safety, and discontinuation.
This study is a multicenter, observational cohort study. Since this study is a retrospective patient chart review of already existing data from clinical practice, no participation from patients is required. Treating physicians or research delegates will review participants’ medical charts and provide anonymized information into an online data collection form.
The online data collection form takes approximately 25 to 40 minutes to complete per patient chart, depending on the number of therapies received by patients. Physicians from participating sites will be asked to provide information on adult patients who initiated a first-line therapy (Sample 1) or a new line of therapy in relapsed/refractory (RR) setting (Sample 2) for treatment of CLL/SLL on or after 12Feb2014.
The study is not designed to test hypotheses, but intended to be a descriptive analysis of characteristics, and treatment patterns/sequences and outcomes among patients with CLL/SLL treated in a real-world setting.
REC name
N/A
REC reference
N/A