SGN-35 in treatment of Hodgkin Lymphoma
Research type
Research Study
Full title
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin Lymphoma (HL).
IRAS ID
14242
Contact name
Peter WM Johnson
Sponsor organisation
Seattle Genetics Inc.
Eudract number
2008-006034-10
Clinicaltrials.gov Identifier
Research summary
Hodgkin Lymphoma -HL- is a cancer of the lymphatic system. HL characteristically contains distinct cells called Reed-Sternberg (HRS) cells. HRS cells have a cell surface protein called CD30. SGN-35 is an antibody drug conjugate (ADC) directed against the CD30 antigen and is being developed to treat patients with CD30-positive haematologic malignancies. The antibody part of SGN-35 sticks to the CD30, whilst the drug component contains a chemotherapeutic agent (MMAE) which can cause tumour cell death. Patients with HL which has relapsed or which did not respond to initial treatment, following receipt of an autologous stem cell transplant (ASCT), have few treatment options available and it is for this group that this new treatment is to be tested. This study of SGN-35 is to determine the antitumour efficacy of SGN-35 as a single agent. The antitumour activity of SGN-35 will be assessed by measurement of the patient tumour burden. Tumour size will be measured by CT scan and also by PET scan. PET scan measurement allows differentiation between active lymphoma and a fibrotic mass. Patients can receive up to one year of treatment and will be followed for both progression of their disease and time of death.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
09/H1008/98
Date of REC Opinion
24 Aug 2009
REC opinion
Further Information Favourable Opinion