R-CHOP vs G-CHOP in previously untreated patients with DLBCL

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMISED TRIAL COMPARING THE EFFICACY OF GA101 IN COMBINATION WITH CHOP (G-CHOP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

• IRAS ID

  74888

• Sponsor organisation

  F Hoffman-La Roche

• Eudract number

  2010-024194-39

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Non-Hodgkin??s lymphoma (NHL) is the most common cancer of the lymphatic system in adults. The majority of NHLs are derived from B-cells, (a particular type of white blood cell). NHL can be divided into aggressive (fast growing) and indolent (slow growing). Diffuse large B cell lymphoma, (DLBCL), is the most common subtype of aggressive NHL accounting for approximately 30% of cases overall.Currently MabThera, in combination with chemotherapy, (R-CHOP), is the standard treatment for diffuse large B-cell lymphoma.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 those that have been killed during treatment.This study aims to find out if GA101 when added to CHOP chemotherapy, (G-CHOP), is more effective in treating DLBCL, than rituximab with chemotherapy (R-CHOP). Patients for this study would not have had any previous treatment for their lymphoma. Patients will commence on up to 8 cycles of CHOP chemotherapy plus either GA101 or rituximab).After the patients have completed the treatment, or withdrawn from treatment, all patients will be checked every 3 months for 2 years and then every 6 months for the following 3 years and then annually until end of study. A patient could be on study for up to 6.5 years.This is an international study with 5 centres planned in the UK.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0225

• Date of REC Opinion

  2 Aug 2011

• REC opinion

  Further Information Favourable Opinion