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Relapsed Diffuse Large B-cell LymphomaPhase 2NCT05068440

Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib

A Phase 2 study testing Zanubrutinib in people with Relapsed Diffuse Large B-cell Lymphoma and Refractory Diffuse Large B-cell Lymphoma, run by BeiGene at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zanubrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
25 sitesChina
Study dates
11 Aug 2021to 31 Mar 2025
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria:
  • 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.
  • Failure to achieve a complete response or partial response following salvage therapy.
  • Failure to collect stem cells or inability to undergo stem cell collection, as assessed by the investigator.

Who cannot join

  • 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
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  • 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:
  • Adequately treated carcinoma in situ of the cervix;
  • Localized basal cell carcinoma or squamous cell carcinoma of the skin; or
  • A previous malignancy that was confined and treated locally (by surgery or other modality) with curative intent.
  • Note: Other protocol-defined inclusion and exclusion criteria may have applied.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital Huifu Branch

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui, 230088

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang, 317000

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: 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

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.

Being tested
Zanubrutinib
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111, Brukinsa

    Administered orally as capsules at a dose of 160 mg twice daily on a continuous dosing schedule.

Study groups in NCT05068440
Study groupRoleWhat they receive
ZanubrutinibExperimentalParticipants 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.
Receives: Drug: Zanubrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. 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.

    Measured: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months

  2. 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.

    Measured: From the date of first documented response until to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months

  3. 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.

    Measured: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months

  4. 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.

    Measured: From first dose until disease progression or death, assessed up to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months

  5. 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.

    Measured: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months

  6. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2021
  2. Study start11 Aug 2021
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068440
Sponsor's protocol ID
BGB-3111-218
Other IDs
CTR20210786
Status last verified
Mar 2026
First submitted
27 Sep 2021
Last updated
25 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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

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