B-cell cancers
Conditions
Interventions
None listed
Sponsors
BeiGene Switzerland GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 = 50,000/mm3 b. Absolute neutrophil count >= 750/mm3 c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 x upper limi
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: * The primary endpoint of the study is safety as assessed by incidence of all treatment-emergent AEs and SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * Progression-free survival (PFS) per investigator assessment * Duration of response (DOR) per investigator assessment * Overall survival (OS) | — |
Countries
Netherlands
Outcome results
None listed