A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Marginal Zone Lymphoma | Relapsed/Refractory Follicular LymphomaThe 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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.
Study Location
Ciusss Du Saguenay Lac St Jean
Ciusss Du Saguenay Lac St JeanChicoutimi, Quebec
Canada
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Newfoundland and Labrador Health Services
Newfoundland and Labrador Health ServicesSt Johns, Newfoundland and Labrador
Canada
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Ciusss de Lestrie Chus
Ciusss de Lestrie ChusSherbrooke, Quebec
Canada
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British Columbia Cancer Agency the Vancouver Centre
British Columbia Cancer Agency the Vancouver CentreVancouver, British Columbia
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
Ciusss de Lest de Lile de Montreal Hopital Maisonneuve RosemontMontreal, Quebec
Canada
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Queen Elizabeth Ii Health Sciences Centre
Queen Elizabeth Ii Health Sciences CentreHalifax, Nova Scotia
Canada
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Centre Integre de Sante Et de Services Sociaux de Chaudiere Appalaches
Centre Integre de Sante Et de Services Sociaux de Chaudiere AppalachesLevis, Quebec
Canada
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Saskatoon Cancer Centre
Saskatoon Cancer CentreSaskatoon, Saskatchewan
Canada
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Juravinski Cancer Centre
Juravinski Cancer CentreHamilton, Ontario
Canada
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Unite de Recherche Clinique Du Cisss Des Laurentides
Unite de Recherche Clinique Du Cisss Des LaurentidesMontreal SaintJerome, Quebec
Canada
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- Study Sponsored By
- BeiGene
- Participants Required
- More Information
- Study ID:
NCT05100862