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Purpose

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC) - Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis - Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator - Relapsed or refractory disease after the last line of therapy - Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 - Adequate organ function

Exclusion Criteria

  • Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i) - Prior therapy with BTK degraders - Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible. - Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug - Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug - Known central nervous system involvement by lymphoma - Clinically significant cardiovascular disease - History of stroke or intracranial hemorrhage within 6 months before first dose of study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: sonrotoclax plus zanubrutinib 		Sonrotoclax and zanubrutinib will be administered in combination.
  • Drug: Sonrotoclax
    Administered orally
    Other names:
    • BGB-11417
  • Drug: Zanubrutinib
    Administered orally
    Other names:
    • Brukinsa
    • BGB-3111
Placebo Comparator
Arm B: placebo plus zanubrutinib 		Placebo and zanubrutinib will be administered in combination.
  • Drug: Zanubrutinib
    Administered orally
    Other names:
    • Brukinsa
    • BGB-3111
  • Drug: Placebo
    Administered orally

Recruiting Locations

University of Alabama At Birmingham Hospital
Birmingham, Alabama 35294-0004

University of Arizona Cancer Center
Tucson, Arizona 85724-0001

Ucsf Fresno
Fresno, California 93701

Kaiser Permanente Southern California
Irvine, California 92618-3734

Yale University Yale Cancer Center
New Haven, Connecticut 06520-8028

Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida 33026-4119

Cleveland Clinic Florida
Weston, Florida 33331-3609

Rush University Medical Center
Chicago, Illinois 60607

University of Chicago Medical Center
Chicago, Illinois 60637-1443

Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804

Mission Cancer and Blood
Waukee, Iowa 50263

Our Lady of the Lake Hospital
Baton Rouge, Louisiana 70808-4365

The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201

Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts 02215-5418

University of Michigan
Ann Arbor, Michigan 48109-1382

The Cancer and Hematology Centers
Grand Rapids, Michigan 49503-2563

Mayo Clinic Rochester
Rochester, Minnesota 55905-0001

Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi 39401-7233

Washington University School of Medicine
St Louis, Missouri 63110-1010

Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska 68803

Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042

The Valley Hospital, Inc
Paramus, New Jersey 07652

Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800

Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina 28204-2990

Duke University
Durham, North Carolina 27710

Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157

University Hospitals
Cleveland, Ohio 44106-1716

Cleveland Clinic Foundation
Cleveland, Ohio 44195-0001

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210-1280

Ohio Health Research Institute
Columbus, Ohio 43214-3907

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033

McGlinn Cancer Institute
West Reading, Pennsylvania 19611-2143

Tennessee Oncology Nashville St Thomas Midtown Clinic
Nashville, Tennessee 37205

Tennessee Oncology
Nashville, Tennessee 37205

Md Anderson Cancer Center
Houston, Texas 77030-3907

Texas Oncology Austin Midtown
Round Rock, Texas 78681-4019

University of Virginia
Charlottesville, Virginia 22908-0817

Virgina Cancer Specialists
Gainesville, Virginia 20155-3257

Vcu Massey Cancer Center
Richmond, Virginia 23298-5026

Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington 98684-6930

University of Wisconsin
Madison, Wisconsin 53792-0001

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
1.877.828.5568
clinicaltrials@beonemed.com

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.