Chronic Lymphocytic LeukaemiaRETRO-idelNCT03582098
Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
An observational study of Chronic Lymphocytic Leukaemia, run by Gilead Sciences at 16 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukaemia
- What is being tested?
- Idelalisib and Rituximab
- Type of treatment
- Pill or oral medicine
- How many people
- 112 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 12 Sep 2018to 26 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United Kingdom15 sites
NHS Grampian
Aberdeen, AB25 2ZN
University Hospital of Wales
Cardiff, CF14 4XW
Cheltenham General Hospital
Cheltenham, GL53 7AN
London Northwest University NHS Trust
Eastcote, HA4 8PD
Medway Maritime Hospital
Gillingham, ME7 5NY
Queen Alexandra Hospital
Harrow, HA1 3UJ
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Milton Keynes University Hospital
Milton Keynes, MK6 5LD
Oxford University Hospitals NHS Trust
Oxford, OX3 7LE
Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, SS0 0RY
Royal Marsden Hospital
Sutton, SM2 5PT
Singleton Hospital
Swansea, SA2 8QA
Royal Cornwall Hospital
Truro, TR1 3LJ
Worcestershire Royal Hospital
Worcester, WR5 1DD
About this study
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
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
- Conditions
- Chronic Lymphocytic Leukaemia
- Being tested
- Idelalisib, Rituximab
- Keywords
- Idelalisib, Zydelig
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called Zydelig®
Tablets were administered in accordance with the marketing authorization.
RituximabDrug
Tablets were administered in accordance with the marketing authorization.
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib and Rituximab | Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. Receives: Drug: Idelalisib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (8)
Overall Survival
Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to 3 months
Starting Dose of Idelalisib
Measured: Up to 3 months
Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib
Measured: Up to 3 months
Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start12 Sep 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukaemiaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582098
- Sponsor's protocol ID
- GS-UK-312-4639
- Acronym
- RETRO-idel
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03582098
- Acronym / sponsor ID
- RETRO-idel / GS-UK-312-4639
- Conditions
- Chronic Lymphocytic Leukaemia
- Keywords
- Idelalisib, Zydelig
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idelalisib and Rituximab | – | Drug: Idelalisib, Drug: RituximabIndividuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdelalisibAlso: Zydelig®Tablets were administered in accordance with the marketing authorization. | Drug | Idelalisib and Rituximab |
| RituximabTablets were administered in accordance with the marketing authorization. | Drug | Idelalisib and Rituximab |
Primary outcome
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.
8 secondary outcomes
Overall Survival
Time frame: Up to 3 months
Progression-Free Survival
Time frame: Up to 3 months
Time to Next Treatment
Time frame: Up to 3 months
Duration of Response
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
Time frame: Up to 3 months
Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib
Time frame: Up to 3 months
Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukaemia, run by Gilead Sciences at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.