Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
A Phase 2, Single-Arm, Open-Label, Multicenter Study of the Bruton Tyrosine Kinase Inhibitor Zanubrutinib in Patients With CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma
2 other identifiers
interventional
65
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2021
CompletedFirst Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedResults Posted
Study results publicly available
March 25, 2026
CompletedMarch 25, 2026
March 1, 2026
3.6 years
September 27, 2021
March 4, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Secondary Outcomes (6)
Complete Response Rate (CRR)
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)
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)
From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Time to Response (TTR)
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)
From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
- +1 more secondary outcomes
Study Arms (1)
Zanubrutinib
EXPERIMENTALParticipants 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.
Interventions
Administered orally as capsules at a dose of 160 mg twice daily on a continuous dosing schedule.
Eligibility Criteria
You may qualify if:
- Participants had histologically confirmed diffuse large B-cell lymphoma, based on the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissue.
- Participants had a positive CD79B gene mutation, as confirmed by a central laboratory.
- Participants had previously received at least one line of adequate systemic therapy for diffuse large B-cell lymphoma, defined as anti-CD20 antibody-based chemoimmunotherapy administered for at least two consecutive cycles, unless disease progression occurred before completion of Cycle 2.
- Participants had relapsed or refractory disease prior to study entry, defined as either:
- Recurrent disease after achieving disease remission, defined as a complete response or partial response, at the completion of the most recent treatment regimen; or
- Stable disease or progressive disease at the completion of the most recent treatment regimen.
- 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:
- Left ventricular ejection fraction less than 50 percent as measured by echocardiogram or multiple gated acquisition scan;
- Diffusing capacity of the lung for carbon monoxide less than 60 percent of the predicted value as measured by pulmonary function testing; or
- Creatinine clearance less than 70 milliliters per minute as demonstrated by nuclear medicine scan or 24-hour urine collection; or comorbid conditions that precluded the use of high-dose therapy and stem cell transplantation due to an unacceptable risk of treatment-related morbidity.
- 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.
You may not qualify if:
- Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to:
- Diffuse large B-cell lymphoma transformed from indolent lymphomas
- Primary mediastinal (thymic) large B-cell lymphoma
- Primary cutaneous diffuse large B-cell lymphoma
- Primary effusion lymphoma
- Central nervous system lymphoma
- Participants had a history of allogeneic stem cell transplantation or chimeric antigen receptor T-cell therapy.
- Participants had prior exposure to a Bruton's tyrosine kinase inhibitor.
- Participants had received any of the following treatments within the specified timeframe prior to the first dose of study drug:
- Corticosteroids administered with antineoplastic intent within two weeks prior to study treatment. A short course (seven days or fewer) of systemic corticosteroids at doses of 20 milligrams per day or less of prednisone equivalent for control of lymphoma-related symptoms was permitted prior to enrollment, provided the corticosteroids were tapered off within five days after initiation of study treatment.
- Chemotherapy or radiotherapy within two weeks.
- Monoclonal antibody therapy within two weeks.
- Investigational therapy within two weeks.
- Chinese patent medicine administered with antineoplastic intent within two weeks.
- Participants had a history of other active malignancies within two years prior to study entry, with the exception of:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (25)
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
Hainan Cancer Hospital
Haikou, Hainan, 570312, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, 310009, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, 317000, China
Related Publications (1)
Li Wang, Fei Li, Qingyuan Zhang, Hui Zhou, Ou Bai, Liping Su, Chunhong Hu, Zhiming Li, Kaiyang Ding, Qunyi Guo, Xiaoling Li, Xiaoxi Zhou, Wenjuan Yu, Shuhua Yi, Zhixia Wei, Wenbin Qian, Feiheng Chen, Guohui Cui, Zhiyu Liang, Qingchao Zeng, Jiaoyan Lyu, Yang Liu, Pan Zhang, Zhirong Shen, Zaixing Shi, Jing Rong, Keshu Zhou, Weili Zhao; BGB-3111-218: Single-arm, open-label, multicenter study of the Bruton tyrosine kinase (BTK) inhibitor zanubrutinib (zanu) in patients with CD79B-mutated Relapsed/Refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Blood 2025; 146 (Supplement 1): 3684. doi: https://doi.org/10.1182/blood-2025-3684
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 5, 2021
Study Start
August 11, 2021
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
March 25, 2026
Results First Posted
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.