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

Gilead Sciences16 sites in 2 countries112 target enrollmentSeptember 12, 2018

ConditionsChronic Lymphocytic Leukaemia

InterventionsIdelalisib Rituximab

DrugsIdelalisib Rituximab

Overview

Phase: Not Applicable
Intervention: Idelalisib
Conditions: Chronic Lymphocytic Leukaemia
Sponsor: Gilead Sciences
Enrollment: 112
Locations: 16
Primary Endpoint: Overall Response Rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 12, 2018

End Date

March 26, 2019

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

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

Arms & Interventions

Idelalisib and Rituximab

Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.

Intervention: Idelalisib

Idelalisib and Rituximab

Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.

Intervention: Rituximab

Outcomes

Primary Outcomes

Overall Response Rate

Time Frame: 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 Outcomes

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)
Overall Survival(Up to 3 months)
Progression-Free Survival(Up to 3 months)
Duration of Response(Up to 3 months)
Starting Dose of Idelalisib(Up to 3 months)