Phase 3 study of BGB-3111 in CLL or SLL
Research type
Research Study
Full title
An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
IRAS ID
232340
Contact name
Talha Munir
Contact email
Eudract number
2017-001551-31
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Chronic lymphocytic leukaemia (CLL) is a malignant disorder of blood cells, called B lymphocytes, which are cells of the immune system. It is the most common leukaemia in the Western world affecting 4.2 in every 100,000 persons per year. Small lymphocytic lymphoma (SLL) and CLL both affect the B lymphocytes but the cancer is found in different locations in the body. In CLL, the cancerous cells are found in the blood but in SLL the cancerous cells are found in the lymph nodes.
This study is a phase 3 open-label, randomised study of BGB-3111 in participants with previously untreated CLL or SLL. The purpose of this study is to compare the effects of the experimental medication BGB-3111, versus a known standard treatment called bendamustine plus rituximab (B+R) on CLL or SLL to find out which is better. In this study, participants will receive either BGB-3111 or the standard chemotherapy treatment B+R.
BGB-3111 blocks a protein in B-cells (immune cells) called Bruton tyrosine kinase (BTK) which helps CLL/SLL cells live and grow. By blocking BTK, BGB-3111 may slow down or stop the activity of CLL/SLL cells, which can lead to improvement in the symptoms associated with CLL/SLL.
Approximately 600 participants, 18 years of age and over, with CLL/SLL in the UK, United States, Australia, and other countries in Europe and Asia, will be enrolled on this study to randomly receive the BGB-3111 or B+R treatment.
The study treatments will both run in 28-day cycles. The total length of time in the study, including screening, treatment, and follow-up periods is expected to be up to 3 years.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0369
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion