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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

ConditionsRelapsed/Refractory Follicular LymphomaMarginal 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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. Each cycle is 28 days in length.

  • 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.

Treatment groups

780 Participants
are divided into 4 treatment groups
Group A: Follicular Lymphoma Arm A: Zanubrutinib plus ObinutuzumabExperimental treatment 2 interventions
Group B: Follicular Lymphoma Arm B: Lenalidomide plus RituximabActive comparator 2 interventions
Group C: Marginal Zone Lymphoma Arm C: Zanubrutinib plus RituximabExperimental treatment 2 interventions
Group D: Marginal Zone Lymphoma Arm D: Lenalidomide plus RituximabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)

Time frame
Approximately 78 months

Secondary outcomes

1

Progression-free Survival As Determined By Investigator Assessment

Time frame
Approximately 87 months
2

Duration Of Response As Determined By BIRC And By Investigator Assessment

Time frame
Approximately 87 months
3

Overall Response Rate As Determined By BIRC And By Investigator Assessment

Time frame
Approximately 87 months
4

Complete Response Rate As Determined By BIRC And By Investigator Assessment

Time frame
Approximately 87 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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