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Comparing two treatment combinations for relapsed lymphoma

A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Phase 3 Interventional BeOne Medicines · NCT05100862

This study is testing whether a new combination of two drugs can help people with relapsed follicular or marginal zone lymphoma live longer without their cancer getting worse compared to another drug combination.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment780 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Drugs / interventionsobinutuzumab, rituximab, zanubrutinib
Locations277 sites (Fresno, California and 276 other locations)
Trial IDNCT05100862 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of zanubrutinib combined with obinutuzumab against lenalidomide combined with rituximab in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. The primary measure of success will be progression-free survival, assessed by an independent review committee using advanced imaging techniques. Participants must have previously received systemic therapy and show a need for further treatment. The study aims to provide insights into which treatment combination offers better outcomes for these specific lymphoma types.

Who should consider this trial

Good fit: Ideal candidates are individuals with histologically confirmed grade 1-3a follicular lymphoma or marginal zone lymphoma who have previously undergone systemic therapy.

Not a fit: Patients with transformed aggressive lymphoma or those requiring ongoing corticosteroid treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with relapsed or refractory lymphoma.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fresno, California and 276 other locations

+227 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Follicular LymphomaMarginal Zone LymphomaZanubrutinibBGB-3111RituximabLenalidomideObinutuzumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.