Clinical Trials List
2019-11-01 - 2026-09-07
Phase III
Recruiting3
ICD-10C82.50
Diffuse follicle center lymphoma, unspecified site
ICD-10C82.59
Diffuse follicle center lymphoma, extranodal and solid organ sites
ICD-10C83.10
Mantle cell lymphoma, unspecified site
ICD-10C83.19
Mantle cell lymphoma, extranodal and solid organ sites
ICD-10C83.30
Diffuse large B-cell lymphoma, unspecified site
ICD-10C83.39
Diffuse large B-cell lymphoma, extranodal and solid organ sites
ICD-10C83.80
Other non-follicular lymphoma, unspecified site
ICD-10C83.89
Other non-follicular lymphoma, extranodal and solid organ sites
ICD-10C84.90
Mature T/NK-cell lymphomas, unspecified, unspecified site
ICD-10C84.99
Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites
ICD-10C84.A0
Cutaneous T-cell lymphoma, unspecified, unspecified site
ICD-10C84.A9
Cutaneous T-cell lymphoma, unspecified, extranodal and solid organ sites
ICD-10C84.Z0
Other mature T/NK-cell lymphomas, unspecified site
ICD-10C84.Z9
Other mature T/NK-cell lymphomas, extranodal and solid organ sites
ICD-10C85.10
Unspecified B-cell lymphoma, unspecified site
ICD-10C85.19
Unspecified B-cell lymphoma, extranodal and solid organ sites
ICD-10C85.20
Mediastinal (thymic) large B-cell lymphoma, unspecified site
ICD-10C85.29
Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites
ICD-10C85.80
Other specified types of non-Hodgkin lymphoma, unspecified site
ICD-10C85.89
Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites
ICD-10C85.90
Non-Hodgkin lymphoma, unspecified, unspecified site
ICD-10C85.99
Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites
ICD-10C86.4
Blastic NK-cell lymphoma
ICD-10C88.4
Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9202.80
Other lymphomas, unspecified, extranodal solid organ sites
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
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Trial Applicant
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Sponsor
BeiGene, Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1.Progression-free survival (PFS) determined by independent central review.
Secondary Outcome Measures :
1.PFS by investigator.
2.Overall response rate (ORR).
3.Duration of response (DOR).
4.Overall survival (OS).
5.Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire.
6.PROs as assessed by the EORTC QLQ-C30 questionnaire.
7.Occurrence and severity of treatment-emergent adverse events (safety and tolerability).
Inclution Criteria
2. Histologically confirmed diagnosis of MCL.
3. No prior systemic treatments for MCL.
4. Measurable disease by CT/MRI.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Adequate marrow and organ function.
Exclusion Criteria
2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant.
3. Clinically significant cardiovascular disease.
4. History of severe bleeding disorder.
5. Unable to swallow capsules or disease significantly affecting gastrointestinal function.
6. Active fungal, bacterial and/or viral infection requiring systemic therapy.
7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
500 participants
