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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)

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ClinicalTrials.gov Identifier: NCT03582098
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukaemia Drug: Idelalisib Drug: Rituximab

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Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : September 12, 2018
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019


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.
Drug: Idelalisib
Tablets were administered in accordance with the marketing authorization.
Other Name: Zydelig®

Drug: Rituximab
Tablets were administered in accordance with the marketing authorization.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 ]
  6. Starting Dose of Idelalisib [ Time Frame: Up to 3 months ]
  7. Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib [ Time Frame: Up to 3 months ]
  8. Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective [ Time Frame: Up to 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582098


Locations
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Ireland
St James Hospital
Dublin, Ireland, 8
United Kingdom
NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Cheltenham General Hospital
Cheltenham, United Kingdom, GL53 7AN
London Northwest University NHS Trust
Eastcote, United Kingdom, HA4 8PD
Medway Maritime Hospital
Gillingham, United Kingdom, ME7 5NY
Queen Alexandra Hospital
Harrow, United Kingdom, HA1 3UJ
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Milton Keynes University Hospital
Milton Keynes, United Kingdom, MK6 5LD
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LE
Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust
Prescot, United Kingdom, L35 5DR
Southend University Hospital NHS Foundation Trust
Southend-On-Sea, United Kingdom, SS0 0RY
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Singleton Hospital
Swansea, United Kingdom, SA2 8QA
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
Worcestershire Royal Hospital
Worcester, United Kingdom, WR5 1DD
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03582098     History of Changes
Other Study ID Numbers: GS-UK-312-4639
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Idelalisib
Zydelig
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action