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

ID#: NCT04002297

Age: 60 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 21, 2019

End Date: August 01, 2026

Contact Information:
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.
Eligibility: 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 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.