Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’
A Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis
Dr Kim Orchard
University Southampton Hospital NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
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.
South Central - Hampshire B Research Ethics Committee
Date of REC Opinion
13 Nov 2015
Further Information Favourable Opinion