- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582098
Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland (RETRO-idel)
April 11, 2019 updated by: Gilead Sciences
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dublin, Ireland, 8
- St James Hospital
-
-
-
-
-
Aberdeen, United Kingdom, AB25 2ZN
- NHS Grampian
-
Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales
-
Cheltenham, United Kingdom, GL53 7AN
- Cheltenham General Hospital
-
Eastcote, United Kingdom, HA4 8PD
- London Northwest University NHS Trust
-
Gillingham, United Kingdom, ME7 5NY
- Medway Maritime Hospital
-
Harrow, United Kingdom, HA1 3UJ
- Queen Alexandra Hospital
-
London, United Kingdom, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
Milton Keynes, United Kingdom, MK6 5LD
- Milton Keynes University Hospital
-
Oxford, United Kingdom, OX3 7LE
- Oxford University Hospitals NHS Trust
-
Prescot, United Kingdom, L35 5DR
- Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
-
Southend-On-Sea, United Kingdom, SS0 0RY
- Southend University Hospital NHS Foundation Trust
-
Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital
-
Swansea, United Kingdom, SA2 8QA
- Singleton Hospital
-
Truro, United Kingdom, TR1 3LJ
- Royal Cornwall Hospital
-
Worcester, United Kingdom, WR5 1DD
- Worcestershire Royal Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Idelalisib and Rituximab
Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
|
Tablets were administered in accordance with the marketing authorization.
Other Names:
Tablets were administered in accordance with the marketing authorization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 3 months
|
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
Time Frame: 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
|
Up to 3 months
|
Time to Next Treatment
Time Frame: 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
|
Up to 3 months
|
Duration of Response
Time Frame: 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
|
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
|
Up to 3 months
|
|
Starting Dose of Idelalisib
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib
Time Frame: Up to 3 months
|
Up to 3 months
|
|
Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective
Time Frame: Up to 3 months
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 12, 2018
Primary Completion (Actual)
March 26, 2019
Study Completion (Actual)
March 26, 2019
Study Registration Dates
First Submitted
June 27, 2018
First Submitted That Met QC Criteria
June 27, 2018
First Posted (Actual)
July 10, 2018
Study Record Updates
Last Update Posted (Actual)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
- Idelalisib
Other Study ID Numbers
- GS-UK-312-4639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukaemia
-
AstraZenecaCLL ConsortiumCompletedB Cell Lymphomas | 11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), | Prolymphocytic Leukaemia (PLL)United States
-
GlaxoSmithKlineCompletedLeukaemia, Lymphocytic, ChronicAustralia, United States, New Zealand
-
GlaxoSmithKlineCompletedLeukaemia, Lymphocytic, Chronic
-
GlaxoSmithKlineCompletedLeukaemia, Lymphocytic, ChronicKorea, Republic of, Japan
-
Novartis PharmaceuticalsCompletedChronic Lymphocytic Leukemia (CLL) | Leukaemia, Lymphocytic, ChronicUnited States, Belgium, Italy, Greece, Russian Federation, Spain, Poland, Czech Republic
-
GlaxoSmithKlineCompletedLeukaemia, Lymphocytic, ChronicJapan
-
GlaxoSmithKlineGenmabCompletedLeukaemia, Lymphocytic, ChronicSweden
-
Novartis PharmaceuticalsCompletedLeukaemia, Lymphocytic, ChronicIndia, United Kingdom, Netherlands, Canada, Germany, Greece, Italy, Poland, Russian Federation, Spain, Taiwan, Thailand, United States, Brazil, Bulgaria, Mexico, Romania, Ukraine
-
Novartis PharmaceuticalsTerminatedLeukaemia, Lymphocytic, ChronicSpain, United States, Belgium, India, United Kingdom, Netherlands, Czechia, Germany, Greece, Italy, Russian Federation, Sweden, Canada, Ireland, Poland, France, Brazil
-
GlaxoSmithKlineCompletedLeukaemia, Lymphocytic, ChronicUnited States, United Kingdom
Clinical Trials on Idelalisib
-
Institut Paoli-CalmettesCHU de ReimsUnknownAutoimmune Cytopenia Associated With Chronic Lymphocytic LeukemiaFrance
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Gilead SciencesTerminatedFollicular Lymphoma | Mantle Cell Lymphoma | B Cell Chronic Lymphocytic Leukemia | B Cells-Tumors | Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)United States
-
Gruppo Italiano Malattie EMatologiche dell'AdultoERIC GroupCompleted
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Gilead Sciences; Celgene Corporation; Biologics...CompletedRelapsed/Refractory Mantle Cell LymphomaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Gilead Sciences; Celgene CorporationCompletedRecurrent Follicular LymphomaUnited States
-
PETHEMA FoundationTerminatedAcute Lymphoblastic LeukemiaSpain
-
Nordic Lymphoma GroupCompletedDiffuse Large B Cell LymphomaDenmark, Sweden
-
Gilead SciencesCompletedChronic Lymphocytic LeukemiaUnited States, France, United Kingdom, Germany, Italy
-
Gilead SciencesCompletedChronic Lymphocytic Leukemia (CLL) | Acute Myeloid Leukemia (AML) | Multiple Myeloma (MM) | Lymphoma, Non-Hodgkin (NHL)United States
-
University of Maryland, BaltimoreGilead Sciences; University of Miami Sylvester Comprehensive Cancer CenterActive, not recruitingFollicular Lymphoma | B-cell Lymphoma | Waldenstrom Macroglobulinemia | Marginal Zone Lymphoma | Lymphoplasmacytic Lymphoma | Non Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Transformed Lymphoma | Indolent LymphomaUnited States