Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
NCT ID: NCT05068440
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2021-08-11
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zanubrutinib
administered orally
Zanubrutinib
administered orally as capsules
Interventions
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Zanubrutinib
administered orally as capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Positive CD79B mutation confirmed by the central laboratory.
3. Previously received at least 1 line of adequate systemic anti-DLBCL therapy, defined as an anti-CD20 antibody-based chemoimmunotherapy for at least 2 consecutive cycles, unless participants had disease progression before Cycle 2
4. Relapsed or refractory (R/R) disease before study entry, defined as either
1. Recurrent disease after having achieved disease remission (CR or partial response \[PR\]) at the completion of the latest treatment regimen.
2. Stable disease or PD at the completion of the latest treatment regimen
5. Ineligible for high dose therapy/stem cell transplantation, which is defined as meeting any of the following criteria:
1. Significant organ dysfunction (eg, left ventricular ejection fraction \< 50% by echocardiogram or multiple gated acquisition scan \[MUGA\], diffuse lung capacity for carbon monoxide \< 60% predicted by pulmonary function test, creatinine clearance \< 70 mL/min shown by nuclear medicine scan or 24-hour urine collection) or comorbidities precluding the use of high dose therapy/stem cell transplantation on the basis of unacceptable risk of treatment-related morbidity
2. Failure to achieve CR or PR with salvage therapy.
3. Failure to collect stem cells or unable to perform stem cell collection as assessed by the investigator.
Exclusion Criteria
2. History of allogeneic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy.
3. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
4. Receipt of the following treatment at the time indicated before the first dose of study drug:
1. Corticosteroid given with antineoplastic intent within 2 weeks, but a short course (≤ 7 days) of systemic corticosteroid treatment at doses ≤ 20 mg/day prednisone equivalent for control of lymphoma-related symptoms is allowed prior to enrollment provided that it is tapered off within 5 days after initiation of study treatment.
2. Chemotherapy or radiotherapy within 2 weeks.
3. Monoclonal antibody within 2 weeks.
4. Investigational therapy within 2 weeks.
5. Chinese patent medicine with antineoplastic intent within 2 weeks.
5. History of other active malignancies within 2 years before study entry, with the exception of (1) adequately treated in-situ carcinoma of the cervix; (2) localized basal cell or squamous cell carcinoma of the skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Hainan Cancer Hospital
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20210786
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-3111-218
Identifier Type: -
Identifier Source: org_study_id
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