MO40598 -Study of Polatuzumab Vedotin in Diffuse Large B-cell Lymphoma
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-GEMOX ALONE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
IRAS ID
261613
Contact name
Andrew McMillan
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2018-003727-10
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy in the world. It is estimated that 509,590 new cases of NHL were diagnosed worldwide in 2018 and 248,724 people died of the disease.
Lymphoma is cancer of the lymphatic system. The lymphatic system (which includes bone marrow, lymph glands, the thymus and the spleen) is part of the body’s immune system and helps fight infection. In certain types of lymphoma, such as follicular lymphoma (FL) or diffuse large B cell lymphoma (DLBCL), cells known as B-cells (which are a type of white blood cell) grow in an uncontrolled way. B cells have a marker known as an antigen on their surface called CD79a.
Polatuzumab vedotin is a new, investigational drug. It is a combination of an antibody to CD79b which attaches to the surface of the B cell and a drug called MMAE. MMAE works to inhibit B-cell division and growth.According to guidelines from the National Comprehensive Cancer Network (NCCN), first-line treatment of DLBCL should consist of the anti-CD20 monoclonal antibody rituximab in combination with a multi-agent chemotherapy.
Central to the development of polatuzumab vedotin is assessment of efficacy and safety when used in combination with other rituximab-chemotherapy regimens. Consistent with its favourable NCCN recommendation, gemcitabine plus oxaliplatin (GemOx) ± rituximab is one such regime for second line treatment of DLBCL.
This study will evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) compared to rituximab, gemcitabine and oxaliplatin alone (R-GemOx) in patients with diffuse large B cell lymphoma (DLBCL) that has returned (relapsed) or stopped responding to previous treatment (refractory).
The study has two stages: 1) an initial safety run-in stage, approximately 10 patients, and 2) a randomized controlled trial (RCT) approximately 206 patients.
In this study patient’s will receive up to 8 cycles of treatment, at 3 weekly intervals, of either Polatuzumab vedotin and Rituximab plus Gemcitabine and Oxaliplatin or Rituximab plus Gemcitabine and Oxaliplatin.
Tests will include PET scans and/or CT scans, blood tests, ECGs, physical examinations, bone marrow biopsies, tumour biopsies and patient questionnaires.
The length of the study is expected to be approximately 25 months
This Global study is sponsored by F. Hoffman La Roche
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
20/EM/0013
Date of REC Opinion
23 Mar 2020
REC opinion
Further Information Favourable Opinion