This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’

  • Research type

    Research Study

  • Full title

    A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis

  • IRAS ID

    174968

  • Contact name

    Dr Kim Orchard

  • Contact email

    kim.orchard@uhs.nhs.uk

  • Sponsor organisation

    University Southampton Hospital NHS Foundation Trust

  • Eudract number

    2015-002231-18

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Amyloidosis is a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function. Systemic AL amyloidosis, which is the commonest amyloid type, occurs in a small proportion of individuals with monoclonal B cell dyscrasias. AL amyloid has a lifetime incidence and is the cause of death of between 0.5-1 per thousand individuals in the UK. It occurs equally in men and women and the median age at diagnosis is 65 years. Without therapy it is inexorably progressive and until recently the median survival was just 6-15 months.
    This is an open labelled Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis (TRALA). There are three treatment levels with step-wise increase of the infused [90Y]-labelled anti-CD66 radiation activity which will be given prior to autologous stem cell transplantation. The total number of participants planned is twelve (12), with a maximum of 18 if all treatment levels are expanded. The objectives of the trial is to review safety and toxicity using [90Y]-anti-CD66 as the sole conditioning prior to autologous stem cell transplantation for AL-amyloidosis and disease response as determined by changes in the free light chain assay (FLCa) pre and post [90Y]-labelled anti-CD66 and post transplantation.

  • REC name

    South Central - Hampshire B Research Ethics Committee

  • REC reference

    15/SC/0565

  • Date of REC Opinion

    13 Nov 2015

  • REC opinion

    Further Information Favourable Opinion

Shape the future of the HRA website.