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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04002297
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : September 7, 2022
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma Drug: zanubrutinib Drug: bendamustine Drug: rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : December 2027

Arm Intervention/treatment
Experimental: zanubrutinib plus rituximab Drug: zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
Other Names:
  • BGB-3111
  • Brukinsa

Drug: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Active Comparator: bendamustine plus rituximab Drug: bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

Drug: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Primary Outcome Measures :
  1. Progression-free survival (PFS) determined by independent central review [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. PFS by investigator [ Time Frame: Up to 7 years ]
  2. Overall response rate (ORR) [ Time Frame: Up to 7 years ]
  3. Duration of response (DOR) [ Time Frame: Up to 7 years ]
  4. Overall survival (OS) [ Time Frame: Up to 7 years ]
  5. Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire [ Time Frame: Up to 7 years ]
  6. PROs as assessed by the EORTC QLQ-C30 questionnaire [ Time Frame: Up to 7 years ]
  7. Occurrence and severity of treatment-emergent adverse events (safety and tolerability) [ Time Frame: Up to 7 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04002297

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Contact: BeiGene 1-877-828-5568

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Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: BeiGene Identifier: NCT04002297    
Other Study ID Numbers: BGB-3111-306
2019-000413-36 ( EudraCT Number )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors