Clinical trial NCT03582098: Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukaemia
Keywords: Idelalisib
Zydelig
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 3 months
measure: Progression-Free Survival
timeFrame: Up to 3 months
measure: Time to Next Treatment
timeFrame: Up to 3 months
measure: Duration of Response
timeFrame: Up to 3 months
measure: 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)
timeFrame: Up to 3 months
measure: Starting Dose of Idelalisib
timeFrame: Up to 3 months
measure: Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib
timeFrame: Up to 3 months
measure: Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James Hospital
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Eastcote
country: United Kingdom
facility: London Northwest University NHS Trust
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Harrow
country: United Kingdom
facility: Queen Alexandra Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Prescot
country: United Kingdom
facility: Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
city: Southend-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: