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

BeiGene logo

BeiGene

Status and phase

Active, not recruiting
Phase 3

Conditions

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Treatments

Drug: zanubrutinib
Drug: bendamustine
Drug: rituximab

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)

510 participants in 2 patient groups

zanubrutinib plus rituximab
Experimental group
Treatment:
Drug: rituximab
Drug: zanubrutinib
bendamustine plus rituximab
Active Comparator group
Treatment:
Drug: rituximab
Drug: bendamustine

Trial contacts and locations

24

Loading...

Central trial contact

BeiGene

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems