A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Sponsor: BeiGene
ClinicalTrials ID:NCT05100862
This study evaluates zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab in relapsed/refractory follicular or marginal zone lymphoma. Eligible participants must have histologically confirmed FL or MZL, prior systemic therapy, and measurable disease. Interventions include oral zanubrutinib, intravenous rituximab, oral lenalidomide, and intravenous obinutuzumab.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), 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 based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with ≥ 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
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
Key
Exclusion Criteria
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
- Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Ucsf Fresno University of California San Francisco Fresno | 93730 | Fresno | California |
| Kaiser Permanente Southern California | 92618 | Irvine | California |
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| Los Angeles Cancer Network | 90017 | Los Angeles | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| UCLA Hematologyoncology | 90095 | Los Angeles | California |
| Scripps Health | 92103 | San Diego | California |
| Sharp Healthcare Sharp Memorial Hospital | 92123 | San Diego | California |
| Baptist Md Anderson Cancer Center | 32207 | Jacksonville | Florida |
| Memorial Cancer Institute, Memorial Healthcare System | 33026 | Pembroke Pines | Florida |
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