A retrospective study of outcomes in relapsed Follicular Lymphoma v1.0

  • Research type

    Research Study

  • Full title

    FOUNDATION UK: A retrospective observational study of outcomes for contemporary therapy in relapsed Follicular Lymphoma

  • IRAS ID

    289092

  • Contact name

    Kim Linton

  • Contact email

    Kim.M.Linton@manchester.ac.uk

  • Sponsor organisation

    University of Manchester

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    Follicular lymphoma is a common mature B cell malignancy with a UK incidence of 3.3/100,000 people per year ( https://hmrn.org accessed June 2020). Most patients have advanced stage disease that follows a protracted and incurable disease course leading to a high overall disease prevalence. Despite advances in front line management, treatment of relapsed and refractory (r/r) FL has not been standardised and data on treatment patterns and clinical outcomes are lacking, presenting significant challenges for therapy selection and novel drug development to optimise clinical outcomes.

    FOUNDATION UK is a NCRI-led, multi-centre, non-interventional, retrospective, observational study aimed at collecting clinical outcome data for patients with r/r FL receiving real world contemporary therapies at participating NHS hospitals. The study will collect pseudonymised data for patients with r/r FL following initial diagnosis and treatment for FL between January 2003-December 2018, and will report on current treatment patterns and clinical outcomes by treatment line, regimen and sequence. Results of this unique study will inform clinical treatment decisions, FL management guidelines, prospective trial design, and regulatory approval of novel FL drugs.

    The study will be conducted at NHS sites in the UK that routinely treat patients with r/r FL. The study will last for two years.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    22/EM/0276

  • Date of REC Opinion

    19 Dec 2022

  • REC opinion

    Further Information Favourable Opinion