BGB-3111-LTE1
Research type
Research Study
Full title
An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B cell Malignancies
IRAS ID
1003360
Contact name
David John Lewis
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2020-000547-31
Research summary
The purpose of the study is to find out whether the study drug zanubrutinib is safe and
effective in the long-term either alone or in combination with other drugs for participants
with various B-cell malignancies who took part in a BeiGene parent study and who are
still benefiting or may benefit from treatment with zanubrutinib, or who are willing to
have long-term survival follow-up.
Participants will be instructed to take the same zanubrutinib dose as they were receiving
on the BeiGene parent study. Participants receiving zanubrutinib together with standardof-
care drug(s) will receive both at the same dose level as in the parent study.
Zanubrutinib-naive participants (ie, those who will receive zanubrutinib for the first time)
will receive a standard dose of 160 mg twice daily (two 80-mg capsules) for a total daily
dose of 320 mg of zanubrutinib. Participants will be asked to take zanubrutinib orally
with a glass of water twice daily at roughly the same time every day. Efficacy
assessments (how well the treatment is tolerated) will be conducted at a minimum of
every 6 months. A safety analysis of data from zanubrutinib single therapy trials
demonstrated that zanubrutinib has been well-tolerated in patients with various B-cell
malignancies.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0125
Date of REC Opinion
6 Oct 2020
REC opinion
Further Information Favourable Opinion