A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Re… (NCT05100862) | Clinical Trial Compass
RecruitingPhase 3
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
United States, Argentina, Australia780 participantsStarted 2022-03-10
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing zanubrutinib plus an anti-CD20 drug against lenalidomide plus rituximab — does my specific history with follicular or marginal zone lymphoma, including what treatments I've already tried, make one of those two arms more or less suitable for me?
2Since the trial is randomized, I wouldn't get to choose which combination I receive — how would you feel about me potentially being assigned to either arm, and is one of them closer to what you'd recommend for me outside of a trial?
3The main thing this study is measuring is how long participants go without their disease progressing, as judged by an independent review committee — based on where my disease stands right now, is progression-free survival the right goal to be prioritizing, or should I be thinking about other outcomes like quality of life or overall survival?
4Are there standard-of-care options you'd consider for my relapsed or refractory lymphoma right now, and how do those compare to what's being tested in this trial, so I can weigh whether enrolling makes sense before trying something else?
5What does joining this trial actually look like day-to-day — how often would I need to come in for visits, monitoring, or labs, and is that realistic given my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)