Status:
COMPLETED
Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
BeiGene
Conditions:
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to determine the maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D), and safety, tolerability, and efficacy of zanubrutinib in combination wit...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed DLBCL, all participants must provide sufficient archival or fresh tumor tissue samples for evaluation by immunohistochemistry (IHC) and Gene Expression Profiling (GEP).
- 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.
- Participants who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
- 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.
- 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..
- Key
Exclusion
- Current or history of central nervous system (CNS) lymphoma.
- Histologically transformed lymphoma.
- History of allogeneic stem-cell transplantation.
- Prior exposure to a BTK inhibitor.
- Prior exposure to lenalidomide or thalidomide.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04436107
Start Date
September 11 2020
End Date
March 28 2024
Last Update
May 23 2025
Active Locations (10)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
2
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
4
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022