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

January 9, 2024 updated by: BeiGene

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural Univ of Medicine
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan university Hospital
      • Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
    • Aichi
      • Nagoyashi, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Toyohashi, Aichi, Japan, 441-8570
        • Toyohashi Municipal Hospital
    • Chiba
      • Chibashi, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Hiroshima
      • Hiroshimashi, Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 2408555
        • Yokohama Municipal Citizens Hospital
      • Yokohamashi, Kanagawa, Japan, 241-8515
        • Kanagawa cancer center
    • Kumamoto
      • Kumamotoshi, Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
    • Miyagi
      • Sendaishi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Okayama
      • Kurashikishi, Okayama, Japan, 710-8602
        • Kurashiki Central Hospital
    • Osaka
      • Osakashi, Osaka, Japan, 543-8555
        • Osaka Red Cross Hospital
    • Tokyo
      • Chuoku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zanubrutinib plus rituximab
Drug: zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
Other Names:
  • Brukinsa
  • BGB-3111
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: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Drug: bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) determined by independent central review
Time Frame: Up to 7 years
Up to 7 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2019

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-306
  • 2019-000413-36 (EudraCT Number)
  • CTR20211594 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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