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A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05100862
Protocol IDs
BGB-3111-308 (primary)
NCI-2023-09690
2022-502548-12-00
CTR20232545
Study Sponsor
BeiGene

Summary

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

  1. Histologically confirmed grade 1-3a FL or MZL
  2. 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
  3. Need for systemic therapy for FL or MZL
  4. Measurable disease by computed tomography or magnetic resonance imaging
  5. Adequate bone marrow, liver and renal function Key
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