RETRO-idel: Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT03582098
Collaborator
(none)
112
16
6.4
7
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Study Details

Study Description

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 Phase

Study Design

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 :
Sep 12, 2018
Actual Primary Completion Date :
Mar 26, 2019
Actual Study Completion Date :
Mar 26, 2019

Arms and Interventions

Arm 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 Names:
  • Zydelig®
  • Drug: Rituximab
    Tablets were administered in accordance with the marketing authorization.

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    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) [Up to 3 months]

    6. Starting Dose of Idelalisib [Up to 3 months]

    7. Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib [Up to 3 months]

    8. Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective [Up to 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St James Hospital Dublin Ireland 8
    2 NHS Grampian Aberdeen United Kingdom AB25 2ZN
    3 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    4 Cheltenham General Hospital Cheltenham United Kingdom GL53 7AN
    5 London Northwest University NHS Trust Eastcote United Kingdom HA4 8PD
    6 Medway Maritime Hospital Gillingham United Kingdom ME7 5NY
    7 Queen Alexandra Hospital Harrow United Kingdom HA1 3UJ
    8 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS
    9 Milton Keynes University Hospital Milton Keynes United Kingdom MK6 5LD
    10 Oxford University Hospitals NHS Trust Oxford United Kingdom OX3 7LE
    11 Whiston Hospital - St Helens And Knowsley Teaching Hospitals NHS Trust Prescot United Kingdom L35 5DR
    12 Southend University Hospital NHS Foundation Trust Southend-On-Sea United Kingdom SS0 0RY
    13 Royal Marsden Hospital Sutton United Kingdom SM2 5PT
    14 Singleton Hospital Swansea United Kingdom SA2 8QA
    15 Royal Cornwall Hospital Truro United Kingdom TR1 3LJ
    16 Worcestershire Royal Hospital Worcester United Kingdom WR5 1DD

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03582098
    Other Study ID Numbers:
    • GS-UK-312-4639
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Apr 12, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gilead Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2019