Chronic Lymphocytic Leukaemia
Conditions
Keywords
Idelalisib, Zydelig
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
Interventions
DRUGIdelalisib
Tablets were administered in accordance with the marketing authorization.
DRUGRituximab
Tablets were administered in accordance with the marketing authorization.
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | Up to 3 months | 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 to Next Treatment | Up to 3 months | 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 |
| Duration of Response | Up to 3 months | 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 |
| Overall Survival | Up to 3 months | Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause |
| 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 | — |
| 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 | — |
Countries
Ireland, United Kingdom
Outcome results
None listed