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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History