B-Cell Malignancies

To evaluate the long-term safety of zanubrutinib regimens in patients with B-cell malignancies who participated in a BeiGene-sponsored parent study of zanubrutinib

tablets

BGB-3111

130

80MG

Incidence of all treatment-emergent adverse
events (AEs) and serious adverse events (SAE),
according to National Cancer Institute Common
Terminology Criteria for Adverse Events
Version 5.0 (NCI-CTCAE v5.0)

1. As part of a BeiGene-sponsored parent study:
a. Currently participating, or
b. Participated recently
2. Intent to continue or start zanubrutinib treatment after occurrence of any of the following:
a. At time of final analysis or study closure of the eligible BeiGene-sponsored parent
study
b. At time of progressive disease after occurrence of either of the following:
i. Patient was receiving zanubrutinib at the time of progressive disease, and the
investigator and patient agree it is in the patient’s best interest to continue
zanubrutinib (following discussion with the medical monitor or designee of the
parent study and this study)
*The following signs and symptoms may be indicators of non-clinically
significant progression warranting continued use of zanubrutinib despite
radiologic progression: absence of clinical symptoms and signs of disease
progression (including clinically significant worsening of laboratory values),
stable ECOG Performance Status, absence of rapid progression of disease or of
progressive tumor at critical anatomical sites that requires urgent alternative
medical intervention. In these scenarios, investigators must inform patients that
continuing treatment is not considered standard in the treatment of cancer but that
in the opinion of the investigator, the patient will continue to benefit from
zanubrutinib.
ii. Patient was receiving a non-BTK inhibitor drug at the time of progressive disease,
and the investigator and patient agree that the patient may clinically benefit from
zanubrutinib treatment (following discussion with the medical monitor or
designee of the parent study and this study

Patients are excluded from the Treatment Phase of this study if they meet any of the following
criteria:
1. Permanently discontinued zanubrutinib treatment in the BeiGene-sponsored parent study
due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of
consent
2. Uncontrolled active systemic infection or recent infection requiring parenteral
anti-microbial therapy
3. Life-threatening illness, medical condition, or organ system dysfunction which, in the
investigator's opinion, could compromise the patient's safety, interfere with the
absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk
4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapy,
or any prohibited concomitant therapy outlined in the protocol
5. Pregnant or lactating woman
6. Inability to comply with study procedures
7. Concurrent participation in another therapeutic clinical study
8. History of progressive disease while receiving a BTK inhibitor (excluding zanubrutinib).
Results of planned response assessments at the end of the parent study must be available
at Screening in order to evaluate eligibility
9. Vaccination with a live vaccine within 35 days prior to first dose of study drug