A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

Trial Profile

A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2017

At a glance

  • Drugs Obinutuzumab (Primary) ; Bendamustine; Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine
  • Indications Follicular lymphoma; MALT lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms GALLIUM
  • Sponsors Chugai; Nippon Shinyaku; Roche
  • Most Recent Events

    • 05 Oct 2017 Results published in the New England Journal of Medicine
    • 22 Sep 2017 According to a Roche media release, the European Commission has approved Gazyvaro (obinutuzumab) in combination with chemotherapy followed by Gazyvaro maintenance in people achieving a response, as a new treatment for previously untreated advanced follicular lymphoma. The approval is based on results from this trial.
    • 31 Aug 2017 According to a Genentech media release, based on the data from this trial, the U.S. Food and Drug Administration (FDA) has accepted supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top