Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Aug 15, 2026
  • participants needed
    500
  • sponsor
    BeiGene
Updated on 15 October 2020
Investigator
Eric Hedrick, MD
Primary Contact
Concord Repatriation General Hospital (4.4 mi away) Contact
+80 other location

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.

Details
Treatment Rituximab, Bendamustine, Zanubrutinib
Clinical Study IdentifierNCT04002297
SponsorBeiGene
Last Modified on15 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Gender: Male or Female
Do you have Mantle Cell Lymphoma; Non-Hodgkin Lymphoma?
70 years of age at the time of informed consent, OR 65-69 years of age with comorbidities precluding autologous stem cell transplantation
Histologically confirmed diagnosis of MCL
No prior systemic treatments for MCL
Measurable disease by CT/MRI
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate marrow and organ function

Exclusion Criteria

Known central nervous system involvement by lymphoma
Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
Clinically significant cardiovascular disease
History of severe bleeding disorder
Unable to swallow capsules or disease significantly affecting gastrointestinal function
Active fungal, bacterial and/or viral infection requiring systemic therapy
Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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