Phase 2 study of BGB-3111 and Obinutuzumab in Follicular Lymphoma
Research type
Research Study
Full title
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma
IRAS ID
232321
Contact name
Rebecca Auer
Contact email
Sponsor organisation
Beigene Ltd
Eudract number
2017-001552-54
Clinicaltrials.gov Identifier
125326, IND Number
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
Follicular Lymphoma is a type of cancer that develops in the lymphatic system, a network of vessels that comprise part of the body’s immune system. It is characterised by an abnormal multiplication of infection-fighting white blood cells called lymphocytes, which then collect in certain parts of the lymphatic system called lymph nodes. Despite existing therapies, this disease can recur after temporary improvement, or stop responding to treatment altogether. Morbidity and mortality of this disease is further compounded by toxicities associated with administered treatments.
This study will compare the effects of BGB-3111 administered in combination with obinutuzumab, versus obinutuzumab monotherapy (single medication treatment) in approximately 210 participants with relapsed/refractory Follicular Lymphoma.
Obinutuzumab, commonly used to treat Follicular Lymphoma, is a ‘humanised’ monoclonal antibody, a protein developed in the laboratory to specifically bind to lymphocytes to induce their destruction.
BGB-3111 blocks a protein in B-cells (subtype of lymphocytes) called Bruton Tyrosine Kinase (BTK), which aid follicular lymphoma cells that have returned to live and grow. By blocking BTK, BGB-3111 may slow down or stop the activity of these abnormal cells. This can in turn can lead to improvement in the symptoms of the disease.
Participants in this study will be randomly allocated to Arm A or Arm B, in order to receive obinutuzumab in combination with BGB-3111, or obinutuzumab as monotherapy, respectively. The approximate duration of the study will be 4 years and will be conducted at 100 sites globally. Only participants with the ability to provide informed consent and above the age of 18 years will be considered for recruitment.
Participants will undergo various tests and procedures including blood and urine sampling, tumour biopsies, electrocardiograms, Positron Emission Tomography (PET) / Computed Tomography (CT) scans, magnetic resonance imaging (MRI) scans and physical examinations in order to evaluate and monitor their disease.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/2064
Date of REC Opinion
22 Jan 2018
REC opinion
Further Information Favourable Opinion