Phase III GA101 or rituximab plus chemo in 1st line indolent NHL
Research type
Research Study
Full title
A multicenter, Phase III, open-label, randomized study in previously untreated patients with advanced indolent non-Hodgkin's Lymphoma comparing GA101 (Ro5072759) plus chemotherapy with rituximab plus chemotherapy followed by GA101 or rituximab maintenance therapy in responders
IRAS ID
70644
Contact name
Graham Collins
Contact email
Sponsor organisation
F Hoffman-La Roche
Eudract number
2010-014132-41
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
Research Summary
Non-Hodgkin's lymphoma (NHL) is the most common cancer of the lymphatic system in adults. The majority of NHLs come from B-cells called lymphocytes (a particular type of white blood cells which mature in the bone marrow). NHL can be divided into aggressive (fast growing) and indolent (slow growing) NHL. Indolent NHLs are a mixed group of malignant lymphomas and account for about one-third of all NHLs. Follicular, lymphoma is the most common subtype of indolent NHL.Currently, MabThera in combination with chemotherapy, is the standard treatment for follicular NHL. GA101 is a new monoclonal antibody and like MabThera, GA101 works by targeting a specific protein, CD20, found on the surface of both healthy and cancerous B-cells and then destroying them. The body will produce new healthy cells to replace the ones that have been killed during treatment.This study aims to find out if this new antibody when added to chemotherapy, is more effective at treating indolent NHL, compared to chemotherapy given in combination with MabThera.Patients for this study would not of had any previous treatment for their lymphoma. They will commence on up to 8 cycles of induction treatment (chemotherapy plus GA101 or MabThera), and then if responsive to treatment move on to receive up to 2 years of maintenance therapy with MabThera or GA101 every 2 months.After the patients have completed the maintenance treatment, or withdrawn from treatment, all patients will be checked every 3 months for up to 5 years. A patient could be on study for up to 7.5 years.This is an international study with up to 50 centres planned in the UK.
Summary of Results
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REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0298
Date of REC Opinion
7 Jun 2011
REC opinion
Further Information Favourable Opinion