Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Chronic Lymphocytic Leukaemia

Intervention / Treatment
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* Drug: Idelalisib
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idelalisib and Rituximab<br>Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. | Drug: Idelalisib<br>* Tablets were administered in accordance with the marketing authorization.<br>* Other names: Zydelig®;Drug: Rituximab<br>* Tablets were administered in accordance with the marketing authorization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause | Up to 3 months | 
| Progression-Free Survival | 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 | Up to 3 months | 
| Time to Next Treatment | 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 | Up to 3 months | 
| Duration of Response | 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 | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idelalisib, Zydelig