GS-UK-312-4639_RETRO-Idel
Research type
Research Study
Full title
A retrospective observational study to evaluate the clinical outcomes and routine management of patients with chronic lymphocytic leukaemia treated with Idelalisib and rituximab in the United Kingdom (UK) and Ireland
IRAS ID
249915
Contact name
Toby Eyre
Contact email
Sponsor organisation
Gilead Sciences
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
This observational study aims to complement the existing knowledge on the use of idelalisib from interventional clinical studies by understanding the characteristics of patients treated with idelalisib and rituximab in routine clinical practice and
evaluate the clinical effectiveness in a real world setting. This will be achieved through making secondary use of data by extracting from a patient medical chart retrospectively on a single occasion. This study will provide further information to improve outcomes for patients with CLL treated with idelalisib-rituximab.
The primary objective is to evaluate the effectiveness of idelalisib and rituximab in patients with Chronic Lymphocytic Leukaemia (CLL) in routine clinical practice in the UK and Ireland. The secondary objective is to describe the safety and clinical outcomes in CLL patients treated with idelalisib and rituximab.Idelalisib received its marketing authorisation in the European Union in September 2014 and was subsequently recommended for use by the National Institute for Health and Care Excellence (NICE) in January 2016 in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or as first line treatment in the presence of 17p deletion and/or TP53 mutation where the patient is not eligible for other therapies.
Zydelig® (idelalisib) works by blocking the effects of an enzyme involved in multiplication and survival of certain white blood cells called lymphocytes. Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0206
Date of REC Opinion
11 Jul 2018
REC opinion
Favourable Opinion