Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
RETRO-idel
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
1 other identifier
observational
112
2 countries
16
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Shorter than P25 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedStudy Start
First participant enrolled
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2019
CompletedApril 12, 2019
April 1, 2019
7 months
June 27, 2018
April 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
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.
Up to 3 months
Secondary Outcomes (8)
Overall Survival
Up to 3 months
Progression-Free Survival
Up to 3 months
Time to Next Treatment
Up to 3 months
Duration of Response
Up to 3 months
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
- +3 more secondary outcomes
Study Arms (1)
Idelalisib and Rituximab
Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
Interventions
Tablets were administered in accordance with the marketing authorization.
Tablets were administered in accordance with the marketing authorization.
Eligibility Criteria
Potential study participants will be identified by sites/hospitals as eligible for inclusion in the study by review of hospital records, including prescribing databases and by members of their direct care team and/or site personnel. The study will only include individuals who initiated idelalisib from September 2014, the date of marketing authorisation, up to and inclusive of 31 December 2017.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (16)
St James Hospital
Dublin, 8, Ireland
NHS Grampian
Aberdeen, AB25 2ZN, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Cheltenham General Hospital
Cheltenham, GL53 7AN, United Kingdom
London Northwest University NHS Trust
Eastcote, HA4 8PD, United Kingdom
Medway Maritime Hospital
Gillingham, ME7 5NY, United Kingdom
Queen Alexandra Hospital
Harrow, HA1 3UJ, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Milton Keynes University Hospital
Milton Keynes, MK6 5LD, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, OX3 7LE, United Kingdom
Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR, United Kingdom
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, SS0 0RY, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1DD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 10, 2018
Study Start
September 12, 2018
Primary Completion
March 26, 2019
Study Completion
March 26, 2019
Last Updated
April 12, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share