BGB-3111 and Ibrutinib in Waldenström’s Macroglobulinema
Research type
Research Study
Full title
A Phase 3, Randomised, Open-Label, Multicentre Study Comparing the Efficacy and Safety of the Bruton’s Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects with Waldenström’s Macroglobulinemia (WM)
IRAS ID
214076
Contact name
Nicola Turvey
Contact email
Sponsor organisation
BeiGene USA, Inc.
Eudract number
2016-002980-33
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Waldenstrom's macroglobulinemia (WM) is a type of blood cancer that affects B cells (a type of white blood cell). White blood cells are the cells that make up the immune system. In WM, the B cells increase in number so much that it interferes with the production of red blood cells. Red blood cells carry oxygen around the body and a shortage of these cells is known as anaemia. People with anaemia often feel tired and get exhausted easily. Another feature of WM is a thickening of the blood. This can cause problems such as poor circulation to the brain, which can lead to symptoms like those from a stroke. There is currently no single accepted treatment for WM and this is due to a lack of understanding about how the disease develops and progresses. When the disease is diagnosed early, current treatments lead to an average survival of 6 years. One drug used in the treatment of WM is ibrutinib. Ibrutinib works by inhibiting (blocking the action of) a protein called Bruton's tyrosine kinase (BTK), which plays a role in the development of B cells.
This clinical trial is comparing ibrutinib to a new BTK inhibitor called BGB-3111. The developers of the new drug want to see how well it works and what side effects are seen.
In this study, participants will have a genetic test before entering the study to determine if they have a mutation in a gene called MYD88. A mutation is an alteration in DNA and MYD88 can help WM cells grow. Participants with a mutation in MYD88 will be randomised to receive ibrutinib while some will be given BGB-3111. Randomisation means that a computer program will decide which of the two drugs the participant will take. Neither the participant nor the study doctor can choose which drug they will take and they have an equal chance of receiving either drug. All participants without the MYD88 mutation will receive BGB-3111 only.
This study is taking place in the UK as well as elsewhere in Europe, the USA, and Australia. The Sponsor of the study is BeiGene USA, Inc. Initially, around 170 participants are expected to be involved in the trial.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0185
Date of REC Opinion
22 May 2017
REC opinion
Further Information Favourable Opinion