Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma MCL, NHL Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Rituximab Bendamustine Hydrochloride Zanubrutinib bendamustine zanubrutinib plus rituximab bendamustine plus rituximab

Eligibility

You can join if…

Open to people ages 65 years and up

  1. ≥ 70 years of age at the time of informed consent, OR 65-69 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

You CAN'T join if...

  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.

Locations

  • University of California Irvine Health accepting new patients
    Orange California 92868 United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas Nevada 89119 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT04002297
Phase
Phase 3
Study Type
Interventional
Last Updated