Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
- Registration Number
- NCT03582098
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the effectiveness of idelalisib and rituximab in adults with chronic lymphocytic leukaemia (CLL) in a real world setting
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Diagnosis of CLL documented within medical records
- Individuals who have received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation at the time of starting idelalisib treatment
- Idelalisib and rituximab initiated on or before 31 December 2017
- Individuals who received idelalisib as part of an interventional clinical trial
- Individuals who received idelalisib for other indications including follicular lymphoma (FL)
- Individuals who previously received idelalisib in combination with ofatumumab
- Use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idelalisib and Rituximab Idelalisib Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. Idelalisib and Rituximab Rituximab Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
- Primary Outcome Measures
Name Time Method Overall Response Rate Up to 3 months Overall Response Rate (ORR) is defined as the proportion of participants who achieve a clinical response as documented within their patient records after the initiation of treatment with idelalisib and rituximab during the observation period.
- Secondary Outcome Measures
Name Time Method Overall Safety and Tolerability of Idelalisib and Rituximab as Measured by the Incidence of Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) Up to 3 months Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib Up to 3 months Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective Up to 3 months Time to Next Treatment Up to 3 months Time to next treatment (TTNT) is defined as the interval from the initiation of treatment with idelalisib and rituximab to the initiation of next treatment
Overall Survival Up to 3 months Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause
Progression-Free Survival Up to 3 months Progression-free survival (PFS) is defined as the interval from the initiation of idelalisib and rituximab to the first documentation of definitive disease progression or death from any cause; definitive disease progression is CLL progression based on documentation in participant records
Duration of Response Up to 3 months Duration of response (DOR) is defined as the interval from the first documentation of clinical response to the earlier of the first documentation of definitive disease progression or death from any cause
Starting Dose of Idelalisib Up to 3 months
Trial Locations
- Locations (16)
NHS Grampian
🇬🇧Aberdeen, United Kingdom
London Northwest University NHS Trust
🇬🇧Eastcote, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
Queen Alexandra Hospital
🇬🇧Harrow, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Milton Keynes University Hospital
🇬🇧Milton Keynes, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Oxford, United Kingdom
Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
🇬🇧Prescot, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
St James Hospital
🇮🇪Dublin, Ireland
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Southend-On-Sea, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom