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A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib

StatusActive, Not Recruiting
PhasePhase 3
Started2020-01-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from BeOne Medicines

Amendment history

2026-08-26
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v25
Primary endpoint(s) modified1 entry, revised
WasIncidence of Adverse Events (AEs)
NowNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Sponsor changed: BeiGene → BeOne Medicines+8 characters
WasBeiGene
NowBeOne Medicines
Primary completion moved earlier: 2027-11 → 2026-12-31
Completion moved earlier: 2028-12 → 2026-12-31
Study sites152→153
Eligibility criteria+57 characters
Currently participating or participated recently in a BeOne (previously BeiGene) parent study Intent to continue or start zanubrutinib treat [...] At time of final analysis or study closure of the eligible BeOne (previously BeiGene) parent study At time of progressive disease (PD); and inves [...] Permanently discontinued from zanubrutinib treatment in the BeOne (previously BeiGene) parent study due to unacceptable toxicity, non-compliance w [...]
Secondary endpoints3 entries, revised
Progression-Free Survival (PFS) per investigator assessment Duration of Response (DOR) per investigator assessment
Study title+59 characters
A Study to Evaluate Long-term Extension StudySafety of Zanubrutinib (BGB-3111) Regimens in Participants With B-cellCell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib
2025-10-20
Study Identification, Study Status, Oversight v24
Primary completion date2026-12→2027-11
Completion date2027-06→2028-12
2025-09-30
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Design v23
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2027-11→2026-12
Completion date2028-12→2027-06
Start date2020-01-21→2020-01-16
Enrollment targetestimated 500→confirmed 955
2024-12-16
Study Status, Contacts/Locations v22
Study sites146→152
2024-10-21
Study Status, Contacts/Locations v21
Study sites100→146
Show 20 earlier versions
2024-10-15
Study Status, Contacts/Locations v20
Study sites104→100
2024-09-27
Study Status, Contacts/Locations v19
Study sites105→104
2024-08-16
Study Status v18
Re-verified, no change to tracked fields
2024-07-30
Study Status, Contacts/Locations v17
Study sitesdetails revised at 1 of 105 sites
2024-07-22
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v16
Trial statusRecruiting→Enrolling by Invitation
Study sites106→105
2024-06-05
Study Status, Contacts/Locations v15
Study sites107→106
2024-04-24
Enrolling by Invitation→Recruiting Study Status, Contacts/Locations v14
Trial statusEnrolling by Invitation→Recruiting
Study sites68→107
2023-10-25
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 68 sites
2023-09-20
Study Status, Contacts/Locations v12
Study sites106→68
2023-06-28
Study Status v11
Primary completion date2024-12→2027-11
Completion date2025-12→2028-12
2022-07-27
Study Status, Contacts/Locations v10
Study sites89→106
2022-04-18
Study Status, Contacts/Locations v9
Study sites76→89
2022-03-04
Study Status, Contacts/Locations v8
Study sites72→76
2022-01-24
Study Status, Contacts/Locations v7
Study sites52→72
2021-08-23
Study Status v6
Re-verified, no change to tracked fields
2020-08-19
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v5
Study sites17→52
Study arms1→2
InterventionsZanubrutinib (Drug)→Tislelizumab (Drug), Zanubrutinib (Drug)
Eligibility criteria+445 characters
KeyCurrently Inclusionparticipating Criteria: Asor partparticipated ofrecently thein a BeiGene parent study Intent to continue or start zanubrutinib treatment after any of the following: CurrentlyAt participatingtime of final analysis or study closure of the eligible BeiGene parent study At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest At an alternative timepoint for an alternative reason Patient who is currently on zanubrutinib treatment: Does not meet any protocol-specified criteria for zanubrutinib hold or permanen [...] [...]
Study title+9 characters
Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
2020-08-03
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Study sites13→17
Eligibility criteria+437 characters
Key Inclusion Criteria: CurrentlyAs enrolledpart inof an eligiblethe BeiGene parent study: Currently participating, or Participated recently treated with zanubrutinib in an eligible BeiGene study Must meet the following criteria within < or = 15 days before first dose of zanubrutinibstudy drug (Zanubrutinib): Platelets ≥ 50,000/mm3 Absolute neutrophil count ≥ 750/mm3 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 23 x upper limit of normal Serum total bilirubin <≤ 2.53 x upper limit of normal (not required for cases with documented Gilbert Syndrome) QT interval corrected [...] [...]
Primary endpoints2 to 1 entries
Incidence of Serious Adverse Events (SAEs)
2020-04-23
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v3
Trial statusRecruiting→Enrolling by Invitation
Study sites13 entries, revised
SCRI Florida Cancer Specialists and Research Institute - South Florida Cancer Specialists and Research Institute - North
2020-01-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-02-27→confirmed 2020-01-21
Study sitesdetails revised at 13 of 13 sites
2020-01-13
Study Identification, Study Status, Study Description, Conditions, Eligibility v1
Start date2019-12→2020-02-27
Eligibility criteria+77 characters
Key Inclusion Criteria: Currently enrolled in an eligible BeiGen [...] e Creatinine clearance ≥ 30 mL/min Written informed consent Key Exclusion Criteria: Permanently discontinued from zanubrutin [...] ncurrent participation in another therapeutic clinical study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study title+4 characters
Long-term Extension Study of Zanubrutinib (BGB-3111) in PatientsParticipants With B-cell Malignancies
2019-11-19
Original filing
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.
Trial Details
NCT Number NCT04170283
Lead Sponsor BeOne Medicines
Conditions B-cell Malignancies
Enrollment 955 participants
Start Date 2020-01-16
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-28