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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2027
  • participants needed
    500
  • sponsor
    BeiGene
Updated on 26 November 2021

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
Condition Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Treatment Rituximab, Bendamustine, Zanubrutinib
Clinical Study IdentifierNCT04002297
SponsorBeiGene
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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