An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients with B-cell Malignancies
- Conditions
- B-cell cancers10024324
- Registration Number
- NL-OMON53996
- Lead Sponsor
- BeiGene Switzerland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria for Patients in Treatment Phase
Each patient eligible to participate in the Treatment Phase of this study must
meet all applicable
criteria:
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:
* For zanubrutinib-naive patients, rationale for initiation of zanubrutinib
treatment must be discussed with and approved by the medical monitor
b. At time of progressive disease (PD) after occurrence of either of the
following:
i Patient was receiving zanubrutinib at the time of progressive disease (PD),
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 Eastern Cooperative Oncology Group
Performance Scale (ECOG PS), 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 (PD), 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)
c. At an alternative timepoint for an alternative reason not described in
Inclusion Criteria 2a and 2b (following discussion with the medical monitor or
designee)
3. Patient who is currently on zanubrutinib treatment:
Does not meet any criteria in Section 6.1.3 for zanubrutinib hold or permanent
discontinuation, and, in the opinion of the investigator, will continue to
benefit from
zanubrutinib treatment
* If patient meets Section 6.1.3 criteria but both investigator and patient
agree it
is in the patient*s best interest to continue zanubrutinib, patient may be
eligible after discussion with and approval by the medical monitor
* Patient who is receiving zanubrutinib in combination with standard-of-care
drug(s): Only has to meet criteria for continued zanubrutinib treatment to be
eligible. Continued treatment with standard-of-care drug(s) is determined by
applicable prescribing information
4. Zanubrutinib-naive patient who either is currently participating in a
BeiGene parent study
or recently participated in a BeiGene parent study:
Must meet the following criteria <= 15 days before first dose of study drug:
a. Platelets >= 50,000/mm3
b. Absolute neutrophil count >= 750/mm3
c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 x
upper
limi
Exclusion Criteria for Patients in Treatment Phase
Each patient eligible to participate in the Treatment Phase of this study must
not meet any of the
following exclusion criteria:
1. Permanently discontinued from 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 antimicrobial
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 (PD) while receiving a BTK inhibitor
(excluding
zanubrutinib)
9. Vaccination with a live vaccine within 35 days prior to first dose of study
drug
Exclusion Criteria for Patients in Survival Follow-up
Each patient eligible to participate in survival follow-up of this study must
not meet any of the
following exclusion criteria:
1. Permanently discontinued from the BeiGene parent study
2. Inability to comply with requests for survival follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints:<br /><br>* The primary endpoint of the study is safety as assessed by incidence of all<br /><br>treatment-emergent AEs and SAEs</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br>* Progression-free survival (PFS) per investigator assessment<br /><br>* Duration of response (DOR) per investigator assessment<br /><br>* Overall survival (OS)</p><br>