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

Chronic Lymphocytic Leukaemia Clinical Trial

— RETRO-idel  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582098
• Other study ID #: GS-UK-312-4639
• Status: Completed
• Start date: September 12, 2018
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Idelalisib
Tablets were administered in accordance with the marketing authorization.
• Rituximab
Tablets were administered in accordance with the marketing authorization.

Locations

Country	Name	City	State
Ireland	St James Hospital	Dublin
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	London Northwest University NHS Trust	Eastcote
United Kingdom	Medway Maritime Hospital	Gillingham
United Kingdom	Queen Alexandra Hospital	Harrow
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Milton Keynes University Hospital	Milton Keynes
United Kingdom	Oxford University Hospitals NHS Trust	Oxford
United Kingdom	Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust	Prescot
United Kingdom	Southend University Hospital NHS Foundation Trust	Southend-On-Sea
United Kingdom	Royal Marsden Hospital	Sutton
United Kingdom	Singleton Hospital	Swansea
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Worcestershire Royal Hospital	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Starting Dose of Idelalisib		Up to 3 months
Secondary	Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib		Up to 3 months
Secondary	Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective		Up to 3 months