Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT ID: NCT04436107
Last Updated: 2025-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2020-09-11
2024-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Zanubrutinib + Lenalidomide 15 mg
Participants received zanubrutinib 160 mg orally twice a day (BID) and lenalidomide 15 mg orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity.
Zanubrutinib
160 mg administered orally twice daily (BID)
Lenalidomide
Administered orally on Days 1-21 each cycle followed by a mandatory 7-day drug-free interval.
Part 1: Zanubrutinib + Lenalidomide 20 mg
Participants received zanubrutinib 160 mg orally BID and lenalidomide 20 mg orally QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity.
Zanubrutinib
160 mg administered orally twice daily (BID)
Lenalidomide
Administered orally on Days 1-21 each cycle followed by a mandatory 7-day drug-free interval.
Part 1: Zanubrutinib + Lenalidomide 25 mg
Participants received zanubrutinib 160 mg orally BID and lenalidomide 25 mg orally QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity.
Zanubrutinib
160 mg administered orally twice daily (BID)
Lenalidomide
Administered orally on Days 1-21 each cycle followed by a mandatory 7-day drug-free interval.
Part 2: Zanubrutinib + Lenalidomide 25 mg
Participants received zanubrutinib 160 mg orally BID and lenalidomide 25 mg orally QD on Days 1-21 of each 28-day cycle until disease progression or unacceptable toxicity.
Zanubrutinib
160 mg administered orally twice daily (BID)
Lenalidomide
Administered orally on Days 1-21 each cycle followed by a mandatory 7-day drug-free interval.
Interventions
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Zanubrutinib
160 mg administered orally twice daily (BID)
Lenalidomide
Administered orally on Days 1-21 each cycle followed by a mandatory 7-day drug-free interval.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Relapsed or refractory disease, defined as either: 1) progression of disease after having achieved disease remission (complete response \[CR\] or partial response \[PR\]) , or 2) stable disease (SD), or progressive disease (PD) at completion of the treatment regimen preceding entry to the study.
3. Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
4. Measurable disease as defined by at least 1 lymph node \>1.5 cm in longest diameter, or at least 1 extra-nodal lesion \>1.0 cm in longest diameter, and measurable in 2 perpendicular dimensions.
5. Received an appropriate first-line therapy for DLBCL,defined as an anti CD20 antibody and an appropriate anthracycline-based combination therapy for at least 2 cycles, unless the patient is intolerant or had disease progression before Cycle 2..
Exclusion Criteria
2. Histologically transformed lymphoma.
3. History of allogeneic stem-cell transplantation.
4. Prior exposure to a BTK inhibitor.
5. Prior exposure to lenalidomide or thalidomide.
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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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jilin Cancer Hospital
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BGB-3111-110
Identifier Type: -
Identifier Source: org_study_id
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