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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

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NCT04002297 · readout ≤ 224 d

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
510actual
Sites
176
Countries
Australia, Austria, Belgium +19

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2019-08-20actualWhen the study began enrolling
Primary completionMar 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2031-09-30estimatedThe whole study's end, after follow-up
First posted2019-06-28actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-18actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Interventions

  • Drug: zanubrutinib — also filed as BGB-3111, Brukinsa
  • Drug: bendamustine
  • Drug: rituximab

Primary outcome

what the primary-completion date above is the date OF
Progression-free survival (PFS) determined by independent central review
measured Up to approximately 7 years

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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