A Study of Zanubrutinib Versus Lenalidomide in Participants With Relapsed/Refractory Marginal Zone Lymphoma
Study Details
Study Description
Brief Summary
The purpose of the study is to compare the efficacy of zanubrutinib plus rituximab versus lenalidomide plus rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: Zanubrutinib plus Rituximab Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first. |
Drug: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) continuously in repeated 28-day cycles.
Other Names:
Drug: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Other Names:
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| Active Comparator: Arm B: Lenalidomide plus Rituximab Participants will receive lenalidomide and rituximab. |
Drug: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Other Names:
Drug: Lenalidomide
Lenalidomide will be administered orally as 20-mg capsules once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Progression-free Survival As Determined By An Independent Review Committee [Approximately 73 months]
Secondary Outcome Measures
- Progression-free Survival As Determined By Investigator Assessment [Approximately 73 months]
- Progression-free Survival As Determined By Independent Review Committee (CT-based Lugano Criteria) [Approximately 73 months]
- Event-free Survival As Determined By An Independent Review Committee (CT-based Lugano Criteria) and By Investigator Assessment [Approximately 73 months]
- Duration Of Response As Determined By An Independent Review Committee And By Investigator Assessment . [Approximately 73 months]
- Overall Response Rate As Determined By An Independent Review Committee And By Investigator Assessment [Approximately 73 months]
- Complete Response Rate As Determined By An Independent Review Committee And By Investigator Assessment [Approximately 73 months]
- Time To Response As Determined By An Independent Review Committee And By Investigator Assessment [Approximately 73 months]
- Overall Survival [Approximately 73 months]
- Health-related Quality Of Life (HRQoL) [Approximately 73 months]
assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30)
- Number of Participants Experiencing Adverse Events (AEs) [From first dose to 30 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of rituximab, or until the date of confirmed disease progression, whichever comes later]
- Event-free Survival As Determined By An Independent Review Committee [Approximately 73 months]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Histologically confirmed CD20-positive MZL.
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Previously received ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy.
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Need for systemic therapy for MZL.
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Measurable disease by computed tomography or magnetic resonance imaging.
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Adequate bone marrow, liver and renal function
Key Exclusion Criteria:
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Transformation to aggressive lymphoma.
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Requiring ongoing need for corticosteroid treatment.
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Clinically significant cardiovascular disease.
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Prior malignancy within the past 2 years.
-
Active fungal, bacterial, and/or viral infection that requires systemic therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Alliance, Inc. | Westbury | New York | United States | 11590 |
Sponsors and Collaborators
- BeiGene
Investigators
- Study Director: Chenmu Du, MD, BeiGene
- Study Director: Xia Zhao, MD, BeiGene
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-3111-308