Brentuximab Vedotin vs Physician's Choice in Patients with CD30+ CTCL
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
IRAS ID
87695
Contact name
Sean Whittaker
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc
Eudract number
2010-024215-14
ISRCTN Number
xx
Research summary
Cutaneous T-cell lymphoma (CTCL) is a rare tumour that presents an unmet need. Most therapies are associated with response rates of only 30% to 49%; and although chemotherapy regimens tend to have higher response rates, the duration of response is often short lived. More effective treatments, with improved toxicity profiles, are needed. The CTCL disease subtypes chosen for inclusion in this study (those expressing CD30 surface antigen) have a similar clinical course of disease: they are indolent and incurable. At present, the treatment goal is to reduce the tumour burden and to provide symptomatic relief to patients. Although a number of treatments have shown to be effective in managing the symptoms of CTCL, the duration of response is often short and many patients with advanced disease rapidly become unresponsive to therapy, presumably due to drug resistance. Brentuximab vedotin is a novel antibody-drug conjugate with anti-tumour activity (directed against the CD30 surface antigen). Currently brentuximab vedotin monotherapy has been studied in two phase 1 studies, and 2 phase 2 studies, for a total of more than 300 patients with relapsed or unresponsive CD30 CTCL. Building on these data, we propose a study designed to investigate whether brentuximab vedotin could increase the rate and length of remission for patients with CD30 CTCL, while reducing the burden of symptoms.
REC name
London - Westminster Research Ethics Committee
REC reference
12/LO/0893
Date of REC Opinion
5 Sep 2012
REC opinion
Further Information Favourable Opinion