Pfizer B3281006-Ph 3 PF-05280586 vs Rituximab in low tumour burden FL
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
IRAS ID
157572
Contact name
Paul Laurence Cervi
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2014-000132-41
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Follicular Lymphoma (FL) is the most common indolent (slow-growing) form of Non-Hodgkin’s Lymphoma (NHL) and accounts for approximately 20-30% of all NHLs. It has a significantly better outcome than more aggressive forms of NHLs like diffuse large B cell lymphoma (DLBCL).
The aim of this study is to compare the effectiveness, safety, drug movement, and immune response of PF-05280586(also known as rituximab-Pfizer) versus rituximab-EU in patients with CD20-positive, low tumour burden follicular lymphoma (LTB-FL). Currently Rituximab is approved for two broad indications: musculoskeletal and connective tissue diseases and B-cell malignancies. Rituximab is an effective therapy for the treatment of patients with CD-20 positive, B-cell malignancies. Rituximab is commercially available in Japan and the United States and is known as Rituxan®, MabThera® is the commercially available product in the European Union and will be referred to as rituximab EU during this study.
Rituximab-Pfizer is biosimilar to Rituximab-EU; this means that it is a biologic drug that has been developed to be similar to an already existing licensed reference drug. It is intended to treat the same diseases as the reference drug using the same dose and treatment regimen.
This study is a 52-week double-blind, randomized, Phase 3 clinical trial to evaluate the effectiveness, safety, drug movement and immune response of rituximab-Pfizer and rituximab-EU in patients with CD20-positive, low tumour burden, follicular lymphoma in the first-line treatment setting. Approximately 394 patients will be randomized in a 1:1 ratio to receive rituximab-Pfizer or rituximab-EU. During the study, patients will receive 4 weekly doses of rituximab-Pfizer or rituximab-EU administered via intravenous infusion.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/1189
Date of REC Opinion
13 Oct 2014
REC opinion
Further Information Favourable Opinion