A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Recruiting now Phase 3 NCT05100862
Run by BeOne Medicines · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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.
Where this trial is running
- Ucsf Fresno University of California San Francisco Fresno, Fresno, California, United States
- Kaiser Permanente Southern California, Irvine, California, United States
- Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
- Los Angeles Cancer Network, Los Angeles, California, United States
- Valkyrie Clinical Trials, Los Angeles, California, United States
- UCLA Hematologyoncology, Los Angeles, California, United States
- Scripps Health, San Diego, California, United States
- Sharp Healthcare Sharp Memorial Hospital, San Diego, California, United States
- Baptist Md Anderson Cancer Center, Jacksonville, Florida, United States
- Ascension Sacred Heart, Pensacola, Florida, United States
- Northwest Georgia Oncology Centers Marietta, Marietta, Georgia, United States
- Cancer Care Specialists of Illinois, Decatur, Illinois, United States
+ 265 more sites.
Who to contact
Study Director BeOne Medicines · 1-877-828-5568 · clinicaltrials@beonemed.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05100862.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.