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

BeiGene

Status and phase: Active, not recruiting; Phase 3

Conditions: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Treatments: Drug: zanubrutinib; Drug: rituximab; Drug: bendamustine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04002297

CTR20211594 (Registry Identifier)

BGB-3111-306

2019-000413-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 510 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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510 participants in 2 patient groups

zanubrutinib plus rituximab

Experimental group

Treatment:

Drug: rituximab

Drug: zanubrutinib

bendamustine plus rituximab

Active Comparator group

Treatment:

Drug: bendamustine

Drug: rituximab