035 Continuation study

• Research type

  Research Study

• Full title

  An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma.

• IRAS ID

  60116

• Contact name

  John Radford

• Sponsor organisation

  Seattle Genetics, inc

• Eudract number

  2010-020363-21

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  This is an open-label treatment, multicenter study in patients on the placebo arm in study SGN35-005 who experience progression of HL. The current study will be conducted in centres participating in SGN35-005 in Eastern Europe, Western Europe, and the United States. Approximately 80 patients will participate in this study. The primary objectives of this study are?½ To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) ?½ To assess the safety and tolerability of brentuximab vedotin.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  10/H1107/59

• Date of REC Opinion

  4 Nov 2010

• REC opinion

  Further Information Favourable Opinion