Recruiting

MAHOGANYZanubrutinib Plus Anti-CD20 Antibodies for Relapsed/Refractory Follicular or Marginal Zone Lymphoma

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Study Aim

This study evaluates whether combining Zanubrutinib with anti-CD20 antibodies can improve progression-free survival in adults with relapsed or refractory follicular or marginal zone lymphoma.

What is being tested

Zanubrutinib

+ Obinutuzumab

+ Rituximab

Drug
Who is being recruted

Hemic and Lymphatic Diseases+9

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2022
See protocol details

Summary

Principal SponsorBeiGene
Study ContactStudy Director BeiGene
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 10, 2022

Actual date on which the first participant was enrolled.

This clinical trial is designed to evaluate the effectiveness of two different treatment combinations for individuals with certain types of lymphoma, specifically relapsed or refractory follicular lymphoma and marginal zone lymphoma. The study aims to determine which treatment is more effective at prolonging the time patients live without their disease worsening. One treatment option includes a combination of zanubrutinib and obinutuzumab for follicular lymphoma, while the other involves zanubrutinib and rituximab for marginal zone lymphoma. This research is important because finding more effective treatments can potentially lead to better outcomes for patients who have not responded well to previous therapies. Participants in this study receive the treatments either orally or through injections, depending on the type of drug. The study closely monitors the patients using advanced imaging techniques like PET/CT scans to assess how the disease responds to the treatments. The main measure of success in this trial is progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse. By comparing these treatments, the study seeks to identify which combination offers a longer period of disease control, helping to guide future treatment decisions.

Official TitleA 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
NCT05100862
Principal SponsorBeiGene
Study ContactStudy Director BeiGene
Last updated: March 19, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

780 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellLymphoma, B-Cell, Marginal Zone

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

6 exclusion criteria prevent from participating
Transformation to aggressive lymphoma

Requiring ongoing need for corticosteroid treatment

Clinically significant cardiovascular disease

Prior malignancy within the past 2 years

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.

Group II

Experimental
Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.

Group III

Active Comparator
Participants will receive lenalidomide and rituximab.

Group IV

Active Comparator
Participants will receive lenalidomide and rituximab.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 277 locations

Recruiting

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, JapanOpen Aichi Cancer Center Hospital Clinical Oncology in Google Maps
Recruiting

Chiba Cancer Center

Chiba, Japan
Recruiting

Matsuyama Red Cross Hospital

Matsuyama, Japan
Recruiting

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Japan
Recruiting
277 Study Centers