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

N/ACompletedNCT03582098

Gilead Sciences112 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Chronic Lymphocytic Leukaemia

Interventions

IdelalisibDRUG

Tablets were administered in accordance with the marketing authorization.

RituximabDRUG

Tablets were administered in accordance with the marketing authorization.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

St James Hospital

Dublin, Ireland

NHS Grampian

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Up to 3 months

Secondary Outcomes

Overall Survival

Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Up to 3 months

Starting Dose of Idelalisib

Data from ClinicalTrials.gov

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