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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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Zanubrutinib (drug), Rituximab (drug), Lenalidomide (drug), Obinutuzumab (drug)
How long the study runs: Study runs about 99 months (dates as stated)
About the drug or intervention: Zanubrutinib — drug: Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles. · Rituximab — drug: Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. · Lenalidomide — drug: Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles. · Obinutuzumab — drug: Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 799
Started: 2022-03-10
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for relapsed/refractory follicular lymphoma
• Phase3 - 799 participants
• 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 take part?

• Ages 18 Years and over
• Diagnosed with relapsed/refractory follicular lymphoma

Where?

• Glasgow - Beatson West of Scotland Cancer Centre
• Greater Manchester - The Christie Hospital
• Huddersfield - Huddersfield Royal Infirmary
• Inverness - Nhs Highland
• +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Relapsed/Refractory Follicular LymphomaMarginal Zone Lymphoma

How this trial compares with your answers

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

CD20

What the study is looking for

✓confirmed by a biopsy grade 1-3a FL or MZL
✓Need for treatment that goes through your whole body for FL or MZL
✓cancer that can be measured on scans by computed tomography or magnetic resonance imaging
✓Adequate bone marrow, liver and kidney function

Who cannot take part

✗Transformation to aggressive lymphoma
✗Requiring ongoing need for corticosteroid treatment
✗Clinically significant cardiovascular disease
✗Prior cancer within the past 2 years
✗Active fungal, bacterial, and/or viral infection that requires treatment that goes through your whole body

See the full 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.