For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

  1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
  2. Histologically confirmed diagnosis of MCL
  3. No prior systemic treatments for MCL
  4. Measurable disease by CT/MRI
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  6. Adequate marrow and organ function

EXCLUSION CRITERIA

Key Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
  3. Clinically significant cardiovascular disease
  4. History of severe bleeding disorder
  5. Unable to swallow capsules or disease significantly affecting gastrointestinal function
  6. Active fungal, bacterial and/or viral infection requiring systemic therapy
  7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Age (in years)

60+

Phase

Phase 3

Participants needed

500

Est. Completion Date

Dec 31, 2027

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT04002297

Study number

BGB-3111-306

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