Phase 3: SGN-35 and BSC vs placebo and BSC in Hodgkin Lymphoma V1

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)

• IRAS ID

  47561

• Contact name

  John Radford

• Sponsor organisation

  Seattle Genetics, Inc.

• Eudract number

  2009-016947-20

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Patients who have primary refractory Hodgkin Lymphoma, or who relapse following a complete remission, have a poor outcome following conventional treatments. High dose therapy followed by an autologous stem cell transplant (ASCT) is frequently used to treat these patients. The current standard of care for patients who have received ASCT, and who are at risk of disease relapse, is to monitor for disease recurrence through supportive care, there is no established therapy indicated to prevent relapse. This study aims to compare the rate of progression free survival using SGN-35 in combination with best supportive care, versus best supportive care and placebo. Patients will be randomly assigned to one of the two treatment arms and will attend clinic for a 30 minute infusion (SGN-05 or placebo) every 21 days, for a maximum of 16 cycles. All patients will be followed up in the long term (maximum of 6 years) to collect information on survival / disease status and information regarding the initiation of alternative lymphoma treatments. A total of 322 patients will be entered into this study from Oncology and Haematology centers in Europe and the United States of America.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  10/H0305/34

• Date of REC Opinion

  21 Jul 2010

• REC opinion

  Further Information Favourable Opinion