Overview

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

Status:
Recruiting

Trial end date:
2027-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

BeiGene

Treatments:

Bendamustine Hydrochloride
Rituximab
Zanubrutinib

Criteria

Key Inclusion Criteria:

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

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.