BGB-3111-214-A Phase 2 OLE Study of BGB-3111 in patients with MZL
Research type
Research Study
Full title
A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients with Relapsed or Refractory Marginal Zone Lymphoma
IRAS ID
254693
Contact name
Kim Linton
Contact email
Sponsor organisation
BeiGene, Ltd. (c/o BeiGene, Inc. USA)
Eudract number
2018-001284-24
Clinicaltrials.gov Identifier
125326, IND Number
Duration of Study in the UK
3 years, 2 months, 3 days
Research summary
This study will look at the effectiveness of an investigational anticancer drug called zanubrutinib in treating relapsed or refractory marginal zone lymphoma (MZL).
Zanubrutinib (also known as BGB-3111) is an experimental drug. This means that it has not been approved for use by the regulatory agencies like Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or any other regulatory agencies outside the UK, including the United States Food and Drug Administration. As of December 2017, zanubrutinib had been given to over 740 participants who were taking part in other research studies with zanubrutinib as a single drug or in combination with another anticancer drug.
Zanubrutinib inhibits the growth of cancerous B-cells that overexpress a protein called Bruton Tyrosine Kinase (BTK). BTK helps memory B lymphocytes cells live and grow. By blocking BTK, zanubrutinib is capable of stopping or slowing down the growth and activity of memory B lymphocytes cells, which may lead to improvement in the symptoms associated with marginal zone lymphoma.
All patients in this study will receive zanubrutinib at a dose of 160 mg orally (by mouth) twice daily (two 80 mg capsules). Treatment will continue until it stops controlling the lymphoma (called disease progression), or in the event of unacceptable side effects, if the participant withdraws their consent, or the study ends. Each treatment cycle lasts 28 days.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0006
Date of REC Opinion
1 Apr 2019
REC opinion
Further Information Favourable Opinion