A Phase 2 interventional study of Zanubrutinib in Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, sponsored by BeiGene. Completed at 25 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
The goal of this clinical trial was to evaluate whether zanubrutinib can effectively treat adults with CD79B-mutant relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Participants received zanubrutinib as monotherapy, underwent regular disease assessments to evaluate treatment response, and were monitored for safety and side effects throughout the study.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's enrollment of 65 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.
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Participants had relapsed or refractory disease prior to study entry, defined as either:
Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria:
a. Presence of significant organ dysfunction, such as:
b. Failure to achieve a complete response or partial response following salvage therapy.
c. Failure to collect stem cells or inability to undergo stem cell collection, as assessed by the investigator.
Exclusion Criteria
Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to:
Participants had received any of the following treatments within the specified timeframe prior to the first dose of study drug:
Participants had a history of other active malignancies within two years prior to study entry, with the exception of:
Note: Other protocol-defined inclusion and exclusion criteria may have applied.
Participants received zanubrutinib 160 mg orally twice daily, administered continuously until disease progression, unacceptable toxicity, withdrawal of consent, initiation of alternative anticancer therapy, loss to follow-up, or study completion.
Drug: Zanubrutinib
Administered orally as capsules at a dose of 160 mg twice daily on a continuous dosing schedule.
Also known as: BGB-3111, Brukinsa
Overall Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
Time frame: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Complete Response Rate (CRR)
CRR was defined as the percentage of participants who achieved a complete response as their best overall response, as determined by investigator assessment according to the Lugano classification for NHL.
Time frame: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Duration of Response (DOR)
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Time frame: From the date of first documented response until to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Progression-free Survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment according to the Lugano classification for NHL. Median PFS was estimated using the Kaplan-Meier method.
Time frame: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Time to Response (TTR)
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by investigator assessment per the Lugano classification for NHL. Only participants who achieved an overall response were included in the analysis.
Time frame: From first dose until disease progression or death, assessed up to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Overall Survival (OS)
OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
Time frame: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it was linked to the study drug.
Time frame: From the first dose until 30 days after the last dose of zanubrutinib, death, or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months
Participants were enrolled at 20 study centers in China.
| Milestone | Zanubrutinib |
|---|---|
| Started | 65 |
| Treated | 65 |
| Completed | 16 |
| Not completed | 49 |
| Withdrew: Death | 32 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Study completed by sponsor | 14 |
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
| percentage of participants | Zanubrutinib |
|---|---|
| Overall Response Rate (ORR) | 46.2 (33.7 to 59.0) |
CRR was defined as the percentage of participants who achieved a complete response as their best overall response, as determined by investigator assessment according to the Lugano classification for NHL.
| Percentage of Participants | Zanubrutinib |
|---|---|
| Complete Response Rate (CRR) | 29.2 (18.6 to 41.8) |
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
| Months | Zanubrutinib |
|---|---|
| Duration of Response (DOR) | 22.7 (2.8 to NA) |
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment according to the Lugano classification for NHL. Median PFS was estimated using the Kaplan-Meier method.
| Months | Zanubrutinib |
|---|---|
| Progression-free Survival (PFS) | 4.3 (2.7 to 5.5) |
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by investigator assessment per the Lugano classification for NHL. Only participants who achieved an overall response were included in the analysis.
| Months | Zanubrutinib |
|---|---|
| Time to Response (TTR) | 2.76 (0.9 to 5.5) |
OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
| Months | Zanubrutinib |
|---|---|
| Overall Survival (OS) | 18.1 (11.4 to NA) |
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it was linked to the study drug.
| Participants | Zanubrutinib |
|---|---|
| At Least One TEAE | 59 |
| At Least One SAE | 16 |
Collected over From the first dose until 30 days after the last dose of zanubrutinib or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zanubrutinib | 32/65 (49.2%) | 16/65 (24.6%) | 57/65 (87.7%) |
| Event | Zanubrutinib |
|---|---|
| PneumoniaInfections and infestations | 4/65 |
| Acute coronary syndromeCardiac disorders | 1/65 |
| Abdominal adhesionsGastrointestinal disorders | 1/65 |
| AscitesGastrointestinal disorders | 1/65 |
| Gastrointestinal perforationGastrointestinal disorders | 1/65 |
| Ileal perforationGastrointestinal disorders | 1/65 |
| IleusGastrointestinal disorders | 1/65 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 1/65 |
| Chest discomfortGeneral disorders | 1/65 |
| Sudden cardiac deathGeneral disorders | 1/65 |
| Event | Zanubrutinib |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 22/65 |
| Neutrophil count decreasedInvestigations | 22/65 |
| Platelet count decreasedInvestigations | 20/65 |
| White blood cell count decreasedInvestigations | 19/65 |
| Aspartate aminotransferase increasedInvestigations | 13/65 |
| Blood lactate dehydrogenase increasedInvestigations | 12/65 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 12/65 |
| PyrexiaGeneral disorders | 11/65 |
| Alanine aminotransferase increasedInvestigations | 11/65 |
| PneumoniaInfections and infestations | 9/65 |
The Safety Analysis Set included all participants who received at least 1 dose of zanubrutinib.
| Age, Continuous(years) | Zanubrutinib |
|---|---|
| Mean | 65.3 ± 9.88 |
| Sex: Female, Male(Participants) | Zanubrutinib |
|---|---|
| Female | 31 |
| Male | 34 |
| Race/Ethnicity, Customized(Participants) | Zanubrutinib |
|---|---|
| Asian | 65 |
| The Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Zanubrutinib |
|---|---|
| 0 (fully Active) | 12 |
| 1 (Limited strenuous activity; light work possible) | 43 |
| 2 (Self-care intact; no work; up >50% of day) | 10 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large B-Cell, Diffuse→
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