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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Transformation to aggressive lymphoma

Requiring ongoing need for corticosteroid treatment

Clinically significant cardiovascular disease

Prior malignancy within the past 2 years

Trial design

Treatments tested in this trial

  • Zanubrutinib
  • Rituximab
  • Lenalidomide
  • Obinutuzumab

Treatment groups

780 Participants
are divided into 4 treatment groups

Locations

277
Argentina
Hospital Aleman1425, CABA Argentina
Hospital Italiano de Buenos Aires1413, Ciudad Autonoma Buenos Aires Argentina
Australia
Concord Repatriation General HospitalNSW 2139, ConcordNew South Wales, Australia
Gosford HospitalNSW 2250, GosfordNew South Wales, Australia

Sponsors and collaborators

BeOne Medicines

Lead sponsor