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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib and Rituximab | Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Tablets were administered in accordance with the marketing authorization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St James Hospital | Dublin | 8 | Ireland | |||
| NHS Grampian |
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| Rituximab | Drug | Tablets were administered in accordance with the marketing authorization. |
|
| 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 | 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 | 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 |
| 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 |
| Aberdeen |
| AB25 2ZN |
| United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Cheltenham General Hospital | Cheltenham | GL53 7AN | United Kingdom |
| London Northwest University NHS Trust | Eastcote | HA4 8PD | United Kingdom |
| Medway Maritime Hospital | Gillingham | ME7 5NY | United Kingdom |
| Queen Alexandra Hospital | Harrow | HA1 3UJ | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Milton Keynes University Hospital | Milton Keynes | MK6 5LD | United Kingdom |
| Oxford University Hospitals NHS Trust | Oxford | OX3 7LE | United Kingdom |
| Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust | Prescot | L35 5DR | United Kingdom |
| Southend University Hospital NHS Foundation Trust | Southend-on-Sea | SS0 0RY | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Singleton Hospital | Swansea | SA2 8QA | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| Worcestershire Royal Hospital | Worcester | WR5 1DD | United Kingdom |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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