Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

Study Overview
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Brief Summary
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This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Official Title
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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

Conditions
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Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: zanubrutinib
* Drug: bendamustine
* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation Histologically confirmed diagnosis of MCL No prior systemic treatments for MCL Measurable disease by CT/MRI Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate marrow and organ function Key Exclusion Criteria: Known central nervous system involvement by lymphoma Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant Clinically significant cardiovascular disease History of severe bleeding disorder Unable to swallow capsules or disease significantly affecting gastrointestinal function Active fungal, bacterial and/or viral infection requiring systemic therapy Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zanubrutinib plus rituximab<br> | Drug: zanubrutinib<br>* Administered as two 80 mg capsules by mouth twice a day<br>* Other names: Brukinsa;Drug: rituximab<br>* Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6<br>|
| Active Comparator: bendamustine plus rituximab<br> | Drug: bendamustine<br>* Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6<br>Drug: rituximab<br>* Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) determined by independent central review |  | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS by investigator |  | Up to 7 years | 
| Overall response rate (ORR) |  | Up to 7 years | 
| Duration of response (DOR) |  | Up to 7 years | 
| Overall survival (OS) |  | Up to 7 years | 
| Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire |  | Up to 7 years | 
| PROs as assessed by the EORTC QLQ-C30 questionnaire |  | Up to 7 years | 
| Occurrence and severity of treatment-emergent adverse events (safety and tolerability) |  | Up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCL, NHL