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Sponsor: BeOne Medicines
Conditions: Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma
Interventions: Zanubrutinib, Rituximab, Lenalidomide, Obinutuzumab
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Key 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.
- Fresno, California, United States
- Irvine, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
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- Marietta, Georgia, United States
- Decatur, Illinois, United States
- Fort Wayne, Indiana, United States
- Waukee, Iowa, United States
- Topeka, Kansas, United States
- Wichita, Kansas, United States
- Lexington, Kentucky, United States
- Shreveport, Louisiana, United States
- Annapolis, Maryland, United States
- Baltimore, Maryland, United States
- Baltimore, Maryland, United States
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- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Hattiesburg, Mississippi, United States
- Columbia, Missouri, United States
- Springfield, Missouri, United States
- Billings, Montana, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- + 240 more on CT.gov