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: 24 Jul 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

    • 21 Jul 2017 According to a Roche media release, the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma. The CHMP's recommendation is based on results from this trial.
    • 25 Jun 2017 Results assessing changes in health-related quality of life (HRQoL) in follicular lymphoma patients (n=1202) receiving Obinutuzumab-based and Rituximab-based therapy, presented at the 22nd Congress of the European Haematology Association.
    • 25 Jun 2017 Results (n=1202) of pooled analysis comparing CT and PET responses in follicular lymphoma patients, presented at the 22nd Congress of the European Haematology Association.
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