GO29365 - Phase Ib/II Study of Polatuzumab Vedotin in r/r FL or DLBCL
Research type
Research Study
Full title
A PHASE IB/II STUDY EVALUATING THE SAFETY, TOLERABILITY AND ANTI-TUMOR ACTIVITY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB (R) OR OBINUTUZUMAB (G) PLUS BENDAMUSTINE (B) IN RELAPSED OR REFRACTORY FOLLICULAR OR DIFFUSE LARGE B-CELL LYMPHOMA.
IRAS ID
158005
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-001361-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
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.
A marker (or antigen) known as CD79b is generally present on the surface of mature B-cells. This marker may allow B-cells to be recognized and targeted with specific drug treatments.
Polatuzumab vedotin is a new, investigational drug. It is a combination of an antibody to CD79b and a drug called MMAE. MMAE is similar in action to vincristine and works to inhibit B-cell division and growth. This study will investigate the safety, tolerability and efficacy of polatuzumab vedotin in patients with FL or DLBCL that has returned (relapsed) or stopped responding to previous treatment (refractory).
In this study, patients will receive one of three treatment regimens: (i) a standard chemotherapy regimen using bendamustine plus rituximab (known as BR); or (ii) BR plus polatuzumab vedotin; or (iii) bendamustine plus obinutuzumab plus polatuzumab vedotin. Patients will receive up to six cycles of treatment, and will be closely monitored during and after treatment. Lymphoma will be monitored via PET scans and/or CT scans before treatment, and at regular intervals following treatment. The study may involve up to 31 study visits, over several years, and will include blood tests, bone marrow biopsies, tumour biopsies and patient questionnaires.
The study is being conducted at specialist cancer centres in the UK and internationally. The study is sponsored by the pharmaceutical company Roche.
REC name
HSC REC A
REC reference
15/NI/0145
Date of REC Opinion
12 Aug 2015
REC opinion
Further Information Favourable Opinion