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A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
NCT04002297 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
Conditions Studied
Interventions
- DRUG rituximab
- DRUG bendamustine
- DRUG zanubrutinib
Study Locations (20)
New South Wales
- Concord Repatriation General Hospital — Concord
- The Tweed Valley Hospital — Cudgen
- Saint Vincents Hospital Sydney — Darlinghurst
- Gosford Hospital — Gosford
- Calvary Mater Newcastle — Waratah
New York
- Icahn School of Medicine At Mount Sinai — New York
- Clinical Research Alliance, Inc — Westbury
Texas
- The University of Texas Md Anderson Cancer Center — Houston
- Joe Arrington Cancer Research and Treatment Center — Lubbock
Queensland
- Sunshine Coast Hospital and Health Service — Birtinya
- Icon Cancer Foundation — South Brisbane
California
- Chao Family Comprehensive Cancer Center — Orange
Illinois
- Rush University Medical Center — Chicago
Massachusetts
- Beth Israel Deaconess Medical Center (Bidmc) — Boston
Michigan
- University of Michigan Health System — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2019-08-20 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04002297
The ClinicalTrials.gov registry entry for NCT04002297 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Mantle Cell Lymphoma; Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which rituximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04002297 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New South Wales, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04002297 about?
NCT04002297 is a clinical study titled "A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation". This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
What is the current status of trial NCT04002297?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2019-08-20. Estimated completion is 2027-12.
What conditions does trial NCT04002297 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04002297?
The interventions under investigation include: rituximab (DRUG), bendamustine (DRUG), zanubrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04002297?
This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04002297 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, Michigan, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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