RETRO-idel: Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Idelalisib and Rituximab Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. |
Drug: Idelalisib
Tablets were administered in accordance with the marketing authorization.
Other Names:
Drug: Rituximab
Tablets were administered in accordance with the marketing authorization.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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]
- Starting Dose of Idelalisib [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of CLL documented within medical records
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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
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Idelalisib and rituximab initiated on or before 31 December 2017
Exclusion Criteria:
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Individuals who received idelalisib as part of an interventional clinical trial
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Individuals who received idelalisib for other indications including follicular lymphoma (FL)
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Individuals who previously received idelalisib in combination with ofatumumab
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Use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | St James Hospital | Dublin | Ireland | 8 | |
2 | NHS Grampian | Aberdeen | United Kingdom | AB25 2ZN | |
3 | University Hospital of Wales | Cardiff | United Kingdom | CF14 4XW | |
4 | Cheltenham General Hospital | Cheltenham | United Kingdom | GL53 7AN | |
5 | London Northwest University NHS Trust | Eastcote | United Kingdom | HA4 8PD | |
6 | Medway Maritime Hospital | Gillingham | United Kingdom | ME7 5NY | |
7 | Queen Alexandra Hospital | Harrow | United Kingdom | HA1 3UJ | |
8 | King's College Hospital NHS Foundation Trust | London | United Kingdom | SE5 9RS | |
9 | Milton Keynes University Hospital | Milton Keynes | United Kingdom | MK6 5LD | |
10 | Oxford University Hospitals NHS Trust | Oxford | United Kingdom | OX3 7LE | |
11 | Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust | Prescot | United Kingdom | L35 5DR | |
12 | Southend University Hospital NHS Foundation Trust | Southend-On-Sea | United Kingdom | SS0 0RY | |
13 | Royal Marsden Hospital | Sutton | United Kingdom | SM2 5PT | |
14 | Singleton Hospital | Swansea | United Kingdom | SA2 8QA | |
15 | Royal Cornwall Hospital | Truro | United Kingdom | TR1 3LJ | |
16 | Worcestershire Royal Hospital | Worcester | United Kingdom | WR5 1DD |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-UK-312-4639