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NCT04002297 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, sponsored by BeiGene.
- Active
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
- 20
- Study locations
NCT04002297: Active Phase 3 study of Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, sponsored by BeiGene.
NCT04002297 is a Phase 3 study of Mantle Cell Lymphoma; Non-Hodgkin Lymphoma that is active but no longer recruiting, run by BeiGene. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04002297, a Phase 3 study of Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by BeiGene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
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 |
What the registry record for NCT04002297 still lists
NCT04002297 is an interventional study that assigns participants to a tested intervention. The registered 510 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
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.
NCT04002297 names 20 study sites across 13 states, led by New South Wales, New York, Texas.
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.
What interventions are being tested in trial NCT04002297?
The interventions under investigation include: rituximab (DRUG), bendamustine (DRUG), zanubrutinib (DRUG).
Who is sponsoring clinical trial NCT04002297?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04002297's enrollment target sits among peer trials
510 729th of 2000 higher than 1,265 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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