BENDAMUSTINE+OBINUTUZUMAB (RO5072759, GA101) in Indolent NHL (Study GAO4753g)

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF BENDAMUSTINE COMPARED WITH BENDAMUSTINE+OBINUTUZUMAB (RO5072759, GA101) IN PATIENTS WITH RITUXIMAB-REFRACTORY, INDOLENT NON-HODGKIN’S LYMPHOMA

• IRAS ID

  57051

• Contact name

  John G Gribben

• Sponsor organisation

  GENENTECH

• Eudract number

  2009-015504-25

• Research summary

  This is an open label study looking at the use of GA101 plus bendamustine versus using bendamustine alone in patients with indolent non-Hodgkin’s Lymphoma that does not respond or no longer responds to treatment containing Rituximab. Participants will be allocated by chance to receive either Bendamustine alone or bendamustine plus the study drug GA101. Approximately 360 patients globally will take part in this study. Participants will be treated until their disease progresses.

• REC name

  Scotland B REC

• REC reference

  10/MRE00/61

• Date of REC Opinion

  17 Aug 2010

• REC opinion

  Favourable Opinion