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

NCT05100862

Active Not RecruitingPhase 3

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (270)
  • Fresno, California, United States
  • Irvine, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Jacksonville, Florida, United States
  • Pensacola, Florida, United States
  • 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
  • Bethesda, Maryland, United States
  • 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