BO22334/A
Research type
Research Study
Full title
A two stage phase III, international, multi center, randomized, controlled, open-label study to investigate the pharmacokinetics, efficacy and safety of rituximab SC in combination with CHOP or CVP versus rituximab IV in combination with CHOP or CVP in patients with previously untreated follicular lymphoma followed by maintenance treatment with either rituximab SC or rituximab IV.
IRAS ID
62614
Contact name
Andrew John Davies
Contact email
Sponsor organisation
Hoffman La Roche
Eudract number
2010-021377-36
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
RITUXIMAB SC COMPARED TO IV RITUXIMAB IN COMBINATION WITH CHEMOTHERAPY AS INDUCTION AND MAINTENANCE THERAPY IN FOLLICULAR LYMPHOMA: Follicular lymphoma (FL) is the most common type of slow-growing Non-Hodgkin’s lymphoma. Rituximab is an antibody therapy targeting a protein known as CD20 on the lymphoma cell surface. Treatment with rituximab in combination with chemotherapy has become the standard of care in the treatment of FL. Rituximab is given as an intravenous (IV) with the initial infusion lasting 3.5-4 hours and subsequent infusions over 2.5 hours. Infusion related reactions may prolong this infusion time. A more convenient formulation is planned, enabling the administration of rituximab as a 12ml subcutaneous (SC) injection given over 5to 6 minutes, with fewer or less intense infusion-related reactions. This study is in two parts, recruiting adult patients with previously untreated FL. In the first part the aim is to establish the rituximab SC does that leads to comparable levels in the blood stream as the IV formulation. In the second part the response rates between the two formulations will be compared. In both parts the safety of the two formulations will be compared. This is a randomised study between C and IV rituximab. The local Investigator will however be able to choose the accompanying chemotherapy, either CHOP or CVP. Rituximab and chemotherapy will be given for up to 8 cycles every 3 weeks. Those patients that have responded (assessed by scans) will receive up to 12 cycles of maintenance treatment given every 2 months for 2 years. During the course of therapy blood samples will be taken to measure the levels of rituximab in the blood. This is an International phase III study sponsored by F. Hoffmann-La Roche Ltd, with 7 centres planned in the UK. It is expected that it will take approximately 29 months to recruit the total number of 380 patients with an overall study duration of 7 years.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
11/H0406/4
Date of REC Opinion
7 Mar 2011
REC opinion
Further Information Favourable Opinion