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Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Patients 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 : October 30, 2019
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 patients 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 : July 2021
Estimated Study Completion Date : August 2026

Arm Intervention/treatment
Experimental: zanubrutinib plus rituximab Drug: zanubrutinib
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day

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. Patient-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

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion Criteria:

  1. Known central nervous system involvement by lymphoma
  2. Patients 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

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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United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89119
Sponsors and Collaborators
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Study Director: Harald Weber, MD BeiGene

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Responsible Party: BeiGene Identifier: NCT04002297     History of Changes
Other Study ID Numbers: BGB-3111-306
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: September 2019
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