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

Official Title

A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

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.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS) determined by independent central review
Secondary Outcome:
  • PFS by investigator
  • Overall response rate (ORR)
  • Duration of response (DOR)
  • Overall survival (OS)
  • Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire
  • PROs as assessed by the EORTC QLQ-C30 questionnaire
  • Occurrence and severity of treatment-emergent adverse events (safety and tolerability)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society