MAB-EASE/MO28107
Research type
Research Study
Full title
A COMPARATIVE, RANDOMIZED, PARALLEL-GROUP, MULTI-CENTRE, PHASE IIIB STUDY TO INVESTIGATE THE EFFICACY OF SUBCUTANEOUS (SC) RITUXIMAB VERSUS INTRAVENOUS (IV) RITUXIMAB BOTH IN COMBINATION WITH CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)
IRAS ID
110973
Contact name
Andrew Hodson
Sponsor organisation
Roche Products Limited
Eudract number
2012-000669-19
Clinicaltrials.gov Identifier
Research summary
F. Hoffmann-La Roche Ltd. (Roche, the study Sponsor) and Genentech Inc. have developed a drug called Mabthera (rituximab) which has been approved to treat DLBCL when it is given intravenously (through a small tube inserted into a vein) and in combination with chemotherapy. Intravenous rituximab is also approved to treat some other cancers. Roche are studying rituximab given by injection into the skin (called subcutaneous rituximab) rather than intravenously (intravenous rituximab). Because this a new way of giving the drug, subcutaneous rituximab is considered an investigational drug. The purpose of this study is to gather more information to see if one of these ways of giving rituximab works better or is safer when treating patients with DLBCL. The study will also gather information about how satisfied participants are with their rituximab treatment as well as how much time is spent in the clinic or hospital to receive their rituximab treatment. Approximately 600 people with previously untreated DLBCL are planned to participate in the study. The study will take approximately 4 years to complete. Patients will receive treatment for up to 6 months, and then will be followed until the study is finished. This follow-up will last for 24 to 39 months depending on how close the study is to completion. Therefore total participation in the study will be between about 2 1/2 years (32 months) and almost 4 years (47 months).
REC name
London - Chelsea Research Ethics Committee
REC reference
12/LO/1707
Date of REC Opinion
12 Dec 2012
REC opinion
Favourable Opinion