Clinical trial · Interventional
A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib
An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up after treatment. Information collected in this study will help health authorities better understand the long-term effects of zanubrutinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zanubrutinib (BGB-3111)
- description
- All participants to receive open-label zanubrutinib
- interventionNames
- Drug: Zanubrutinib
- type
- EXPERIMENTAL
- label
- Zanubrutinib in combination with Tislelizumab
- description
- Participants to receive the combination as in the parent study (Australia Only)
- interventionNames
- Drug: Zanubrutinib
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
1. Currently participating or participated recently in a BeOne (previously BeiGene) parent study 2. Intent to continue or start zanubrutinib treatment after any of the following: 1. At time of final analysis or study closure of the eligible BeOne (previously BeiGene) parent study 2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest 3. At an alternative timepoint for an alternative reason 3. Patient who is currently on zanubrutinib treatment: Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment 4. Zanubrutinib-naive patient: Must meet the following criteria ≤ 15 days before first dose of study drug: 1. Platelets ≥ 50,000/mm3 2. Absolute neutrophil count ≥ 750/mm3 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal 4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome) 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec 6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure 7. Creatinine clearance ≥ 30 mL/min 5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control. Key Exclusion Criteria: 1. Permanently discontinued from zanubrutinib treatment in the BeOne (previously BeiGene) parent study due to unacceptable toxicity, non-compliance 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 participant'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 therapies, 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) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
References
Publications (2)
- DERIVEDGarcia-Sanz R, Owen RG, Jurczak W, Dimopoulos MA, McCarthy H, Cull G, Opat SS, Castillo JJ, Kersten MJ, Wahlin BE, Grosicki S, Prathikanti R, Tian T, Allewelt H, Cohen AC, Tam CS. Outcomes after transition from ibrutinib to zanubrutinib in patients with Waldenstrom macroglobulinemia from the ASPEN study. Blood Adv. 2025 Dec 23;9(24):6538-6546. doi: 10.1182/bloodadvances.2024015596. PMID 40924923
- DERIVEDMoslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641. PMID 38502198